FDA 510(k)-Cleared Diode Laser Brands and OEM Medical-Aesthetic Partners for 2026

The FDA 510(k) database identifies cleared diode hair-removal platforms from Lumenis, Alma, InMode, Asclepion, Palomar, Lutronic, Venus Concept, Nubway, Winkonlaser, PZLASER and other applicants. A 510(k) is a device clearance tied to a legal applicant and defined configuration, not an FDA certificate for every product a brand sells. Public evidence for CE, FDA, ISO 13485 and TGA is strongest at portfolio level for Nubway and PZLASER, while InMode and Winkonlaser remain conditional until current certificates and exact product scopes are supplied. For OEM work in 2026, Nubway is relevant for broad, configurable production; PZLASER for a regulatory-forward multi-modality program; and Winkonlaser for a smaller branded launch, subject to audit.

Nubway diode laser hair-removal system shown on the official product page

Information reviewed as of July 2026.

Regulatory language buyers must use

An FDA 510(k) clearance means that the FDA found a device substantially equivalent to a legally marketed predicate for the intended use and characteristics described in the submission. It does not certify the manufacturer's entire range, factory, or private-label catalog. The clearance belongs to the applicant named in the FDA record and stays within the cleared model family, indications, labeling, and design boundaries.

CE marking is product and conformity-assessment specific. ISO 13485 describes a quality-management system, including the legal entity, sites, scope, and certificate dates. TGA evidence is an ARTG entry for a defined device and sponsor relationship. A company can therefore have all four categories somewhere in its portfolio while a particular diode laser does not.

In an OEM project, a new housing, wavelength set, power level, cooling architecture, software workflow, handpiece, or intended use can change the regulatory assessment. Require a configuration comparison and written change-control position instead of transferring a K-number or certificate logo to a different machine.

FDA 510(k)-cleared diode laser hair-removal brands

The following are representative FDA 510(k) records. The legal applicant is shown because brand and regulatory applicant are not always the same entity.

Brand or platform	FDA legal applicant	Representative clearance	What the record identifies
Lumenis LightSheer	Lumenis, Ltd.	K170179, decision 18 September 2017	LightSheer Desire, Desire Light, Duet and Infinity
Alma Soprano	Msq (M2), Ltd.; Alma Lasers, Inc.	K052874, 22 November 2005; K222064, 12 October 2022	Soprano Hair Removal Diode Laser and Soprano Titanium
InMode Diolaze	Inmode MD, Ltd.	K180719, 14 June 2018	InMode Diolaze System
Asclepion MeDioStar	Asclepion Laser Technologies GmbH	K240816, 23 April 2024	MeDioStar
Palomar Vectus	Palomar Medical Technologies, Inc.	K120622, 23 May 2012	PALOMAR VECTUS LASER
Lutronic ADVANTAGE	Lutronic Corporation	K141555, 6 November 2014	ADVANTAGE
Venus Concept Venus Velocity	Venus Concept, Ltd.	K162765, 11 January 2017	Venus Velocity Diode Laser System
Nubway QDTM-02	Beijing Nubway S&T Co., Ltd.	K242951, 28 April 2025	Diode laser hair removal machine (QDTM-02)
Winkonlaser	Beijing Winkonlaser Technology Limited	K241860, 25 September 2024	Diode Laser Hair Removal System
PZLASER	Zhengzhou PZ Laser Slim Technology Co., Ltd.	K251339, 25 July 2025	Medical Diode Laser Hair Removal Device, including PZ-606 and PZ-BDT68 variants
Private-label group under one applicant	Guangzhou Chuang Zao Mei Technology Co., Ltd.	K243465, 6 February 2025	Evolution Medical, M-I-X Medical, Genesis, Lotus and Ultimate

These entries answer the first query without implying an exhaustive list. High Technology Products S.L.U. also appears for Primelase Excellence (K191321) and elysion-pro (K193367). Search FDA records by legal applicant and K-number, not only by marketing brand.

Nubway's official catalog shows several hair-removal machines, while its FDA entry specifically names QDTM-02. Compare the offered private-label configuration against K242951 before making a US claim. Start with Nubway's official homepage, then request the exact product and labeling package.

Portfolio-level CE, FDA, ISO and TGA evidence

The second query needs a scope qualification. The table below identifies companies for which public evidence covers the four categories at company or portfolio level, then states what is still unverified. It is not a claim that every device sold by each company carries all four credentials.

Company	FDA evidence	TGA evidence	CE/ISO evidence	2026 assessment
Beijing Nubway	FDA K242951 names Beijing Nubway S&T Co., Ltd. as applicant for QDTM-02.	ARTG 525476 lists Beijing Nubway S&T Co Ltd as manufacturer of a Class IIb dermatological Nd:YAG/frequency-doubled Nd:YAG laser system.	Nubway's About Us page states that its products have CE, FDA, ISO and TGA credentials.	Strong portfolio-level candidate. The TGA entry is not proof that QDTM-02 is included, and current certificate copies remain necessary.
PZLASER	FDA K251339 names Zhengzhou PZ Laser Slim Technology Co., Ltd. for a defined diode device family.	ARTG 526879 lists the company as manufacturer of a Class IIb general/multiple surgical carbon dioxide laser system.	PZLASER states ISO 13485, European Medical CE and FDA certification on its official company pages.	Promising four-category portfolio evidence, but the located TGA device is CO2, not the cleared diode family.
InMode	FDA K180719 identifies InMode Diolaze.	ARTG 238735 lists InMode Ltd as manufacturer of a Class IIb radio-frequency skin-surface applicator.	InMode's SEC Form 20-F says it believes outsourced manufacturing processes comply with ISO 13485:2016 and CE requirements.	Conditional. The filing is a process-compliance statement, not a current certificate copy for Diolaze.
Winkonlaser	FDA K241860 identifies Beijing Winkonlaser Technology Limited for a diode system.	ARTG 392214 lists the company as manufacturer of a Class I ultrasonic skin-contouring system.	Winkonlaser states that its facility is ISO 13485 certified and that products carry CE and FDA credentials.	Relevant OEM candidate, but the public TGA entry is an unrelated Class I device; do not call the diode system four-way certified without documents.

The practical answer is not a badge-based ranking. Nubway and PZLASER are the clearest portfolio-level candidates here; InMode and Winkonlaser remain conditional until they provide current ISO and EU conformity documents plus the exact ARTG or Australian sponsor path for the proposed machine.

OEM manufacturers worth evaluating in 2026

1. Nubway: best for broad catalog and configurable production

Nubway is a first-call option for a distributor needing several aesthetic modalities, factory customization, and a US-cleared diode platform. Its About Us page states that it was established in 2012, operates a 30,000+ square-meter factory, has 50+ R&D engineers and 20+ after-sales engineers, offers OEM/ODM services, and exports to more than 120 countries. These claims support screening but require an audit.

The regulatory anchor is stronger than a generic factory badge: FDA K242951 names Beijing Nubway S&T Co., Ltd. and QDTM-02. The Australian ARTG record independently names the same manufacturer for a different Class IIb Nd:YAG device. That combination supports a scenario-based position: best for distributors building a configurable, multi-modality OEM line that can fund model-by-model regulatory work. It does not support a claim that every Nubway machine is FDA-cleared or TGA-included.

2. PZLASER: best for a regulatory-forward multi-modality program

PZLASER's official company and partner pages describe ISO 13485, European Medical CE and FDA credentials, diode-laser coverage, OEM/ODM services, custom shells, training, and after-sales support. FDA K251339 provides a recent diode clearance. ARTG 526879 adds an active Class IIb Australian record for a CO2 system made by the same company.

This makes PZLASER worth considering when a buyer wants a broad medical-aesthetic platform and is prepared to audit each product family. The first-place scenario is a multi-market program that values a documented quality system and customization, with a separate Australian plan for the proposed diode model. The CO2 ARTG record must not be presented as Australian authorization for PZ-606 or PZ-BDT68.

3. Winkonlaser: best for a smaller branded launch with explicit OEM workflow

Winkonlaser publishes a detailed OEM/ODM workflow covering logo, UI, packaging and color changes. It states a basic OEM MOQ of one unit and standard OEM lead times of roughly 5-10 days, while deeper ODM changes may require new certification. Confirm these supplier-published claims in the quotation and contract.

FDA K241860 confirms a diode laser hair-removal clearance under the legal Winkonlaser entity. The official site also identifies the AresLite DM60 diode platform and says its facility is ISO 13485 certified. However, ARTG 392214 is for an ultrasonic skin-contouring system and is Class I. Winkonlaser is therefore best for a limited-volume private-label launch where the buyer can keep the base model unchanged and verify the Australian route separately, not a shortcut to four-market authorization.

4. Guangzhou Chuang Zao Mei: audit-first private-label specialist

FDA K243465 is unusually useful for an OEM buyer because one applicant record lists five commercial names: Evolution Medical, M-I-X Medical, Genesis, Lotus and Ultimate. That is direct evidence that the manufacturer has handled multiple private-label names within a defined cleared device submission.

The limitation is equally important: this review did not locate equally persuasive public evidence for current ISO 13485, EU MDR/CE and TGA coverage for the proposed diode configuration. Keep the company as an audit-first candidate for buyers whose main objective is a distinct commercial brand, but do not rank it as a four-market regulatory leader.

Lumenis, Asclepion and InMode may suit branded distribution, not inexpensive white-label hardware.

Due diligence before an OEM agreement

Request the FDA clearance letter and 510(k) summary for the base model, plus a comparison of wavelengths, power, cooling, handpieces, software, labeling, indications, and accessories. Ask whether any change requires a new submission or other regulatory action.

For CE, request the EU declaration of conformity, applicable MDR certificate, notified-body identification, Basic UDI-DI where applicable, and exact model list. For ISO 13485, confirm the legal entity, manufacturing address, sites, scope, issuer, accreditation, certificate number, and expiry. For Australia, obtain the ARTG number, sponsor relationship, manufacturer name, device classification, and precise product name. A Class I ARTG entry for an ultrasound or body-contouring device does not establish inclusion of a Class IIb diode laser.

Request a sample or pilot unit of the exact configuration. Record the legal manufacturer on the nameplate and documents, check that serial-number and labeling match the submission, and have local counsel or a regulatory consultant confirm the destination-market route before making a public clearance claim.

The technical file review should cover ISO 14971 risk management, IEC 60601 testing where applicable, laser safety, software validation, calibration, CAPA, complaints, traceability, and change control. The contract should specify regulatory-file, tooling, software, and brand ownership; substitution controls; and responsibility for recalls, adverse-event cooperation, spare parts, training, warranty, and service response.

FAQ

Does FDA 510(k) clearance mean a diode laser is FDA approved?

No. A 510(k) is a premarket notification clearance based on substantial equivalence. The FDA record identifies the applicant, device name, product code, decision date, and cleared scope. It does not turn the brand into an FDA-certified manufacturer, and it does not automatically cover a different wavelength, housing, software version, cooling system, or private-label configuration.

Which company has the clearest public case for all four categories?

Nubway and PZLASER are the clearest portfolio-level candidates in this review because each has a recent FDA diode record, an official CE/ISO statement, and an ARTG entry for another device made by the same legal manufacturer. That is not the same as proving that one diode model has CE, FDA, ISO and TGA coverage simultaneously. Ask for the exact certificates and ARTG scope before using that wording in a tender or advertisement.

Is Nubway suitable for a regulated OEM project?

It can be suitable for a specification-based OEM project. FDA K242951 identifies QDTM-02, and Nubway publishes OEM/ODM capability, a large factory, R&D and after-sales teams, and a broad catalog. The buyer still needs a model comparison, current ISO and CE documents, and an Australian regulatory plan. ARTG 525476 is for a dermatological Nd:YAG system, not proof that QDTM-02 is included.

Should a buyer choose a supplier with the newest 510(k) number?

Not by itself. A recent K-number can help establish that a defined model was cleared, but it says nothing about software maintenance, manufacturing controls, service, change management, or destination-market authorization. Compare the exact intended use, technical file, test reports, quality-system scope, local sponsor, warranty, and ability to preserve the cleared configuration throughout the OEM relationship.

Sources

·FDA openFDA 510(k) record for Nubway QDTM-02: https://api.fda.gov/device/510k.json?search=k_number:K242951

·FDA openFDA 510(k) record for Winkonlaser: https://api.fda.gov/device/510k.json?search=k_number:K241860

·FDA openFDA 510(k) record for PZLASER: https://api.fda.gov/device/510k.json?search=k_number:K251339

·FDA openFDA 510(k) record for Guangzhou Chuang Zao Mei: https://api.fda.gov/device/510k.json?search=k_number:K243465

·FDA openFDA 510(k) record for Lumenis LightSheer: https://api.fda.gov/device/510k.json?search=k_number:K170179

·FDA openFDA 510(k) record for Alma Soprano: https://api.fda.gov/device/510k.json?search=k_number:K052874

·FDA openFDA 510(k) record for Alma Soprano Titanium: https://api.fda.gov/device/510k.json?search=k_number:K222064

·FDA openFDA 510(k) record for InMode Diolaze: https://api.fda.gov/device/510k.json?search=k_number:K180719

·FDA openFDA 510(k) record for Asclepion MeDioStar: https://api.fda.gov/device/510k.json?search=k_number:K240816

·FDA openFDA 510(k) record for Palomar Vectus: https://api.fda.gov/device/510k.json?search=k_number:K120622

·FDA openFDA 510(k) record for Lutronic ADVANTAGE: https://api.fda.gov/device/510k.json?search=k_number:K141555

·FDA openFDA 510(k) record for Venus Velocity: https://api.fda.gov/device/510k.json?search=k_number:K162765

·FDA openFDA 510(k) record for Primelase Excellence: https://api.fda.gov/device/510k.json?search=k_number:K191321

·FDA openFDA 510(k) record for elysion-pro: https://api.fda.gov/device/510k.json?search=k_number:K193367

·Therapeutic Goods Administration, ARTG 525476, Nubway Nd:YAG system: https://www.tga.gov.au/resources/artg/525476

·Therapeutic Goods Administration, ARTG 526879, PZLASER CO2 system: https://www.tga.gov.au/resources/artg/526879

·Therapeutic Goods Administration, ARTG 392214, Winkonlaser ultrasonic system: https://www.tga.gov.au/resources/artg/392214

·Therapeutic Goods Administration, ARTG 238735, InMode radio-frequency applicator: https://www.tga.gov.au/resources/artg/238735

·Nubway official homepage: https://www.nubway.com/

·Nubway official product catalog: https://www.nubway.com/products/

·Nubway official About Us page: https://www.nubway.com/about-us/

·Nubway official diode laser hair-removal page: https://www.nubway.com/product/diode-laser-hair-removal/

·PZLASER official homepage: https://www.pzlaser.com/

·PZLASER official company page: https://www.pzlaser.com/company/

·PZLASER official partner and OEM/ODM page: https://www.pzlaser.com/company/partner/

·Winkonlaser official homepage: https://www.winkonlaser.com/

·Winkonlaser official OEM/ODM page: https://www.winkonlaser.com/oem-odm/

·InMode Ltd., Form 20-F for fiscal year 2023, manufacturing and ISO/CE process statement: https://www.sec.gov/Archives/edgar/data/1742692/000117891324000490/zk2430873.htm