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Device Explorer · FDA GUDID · GMDN 47417

Hair growth laser device

An electronic, portable, head-worn or hand-operated device intended to be operated by a layperson affected by scalp hair loss (i.e., receding hairline/baldness due to androgenic alopecia) to stimulate hair growth on the scalp through the application of schedul

US‑registered devices144in commercial distribution
Companies28labelers on GUDID
Single‑use7%of device records
Sterile0%labelled sterile
Prescription2%Rx‑only share
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Share of device records

Capillus, Llc2719%
Lexington International, Llc1712%
Lasercap Company1611%
Shenzhen Kaiyan Medical Equipment Co,. Ltd128%
Revian, Inc.96%
Xtrallux, Llc96%
Hubei Yjt Intelligent Technology Group Co., Ltd.86%
Xuzhou Kernel Medical Equipment Co., Ltd.53%

Top labelers

CompanyDevicesShare
Capillus, Llc2719%
Lexington International, Llc1712%
Lasercap Company1611%
Shenzhen Kaiyan Medical Equipment Co,. Ltd128%
Revian, Inc.96%
Xtrallux, Llc96%
Hubei Yjt Intelligent Technology Group Co., Ltd.86%
Xuzhou Kernel Medical Equipment Co., Ltd.53%
Cosmo Far East Technology Limited43%
Dongguan Boyuan Intelligent Technology Co.,Ltd43%
Shang Far Biotechnology Co.43%
10589578 Canada Inc.43%

Company = labeler of record on GUDID. 28 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Diode Laser CapHair Growth DeviceBreoideatherapyLIFEPRO FITNESSIrradiation Cosmetic DeviceIrradiation Aesthetic DeviceiHelmetCurrentBody Skin™NOOANCELaser Hair Growth SystemLaser Therapy Hair Growth CombLaser CapKernelKERNELBeauty Pie

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
OAPLaser, Comb, Hair163
ISAMassager, Therapeutic, Electric2
NDPAccessories, Implant, Dental, Endosseous1

GMDN & GCC registration

  • GMDN code 47417 · non‑implantable
  • Single‑use 7% · sterile 0% · Rx‑only 2% · OTC 83%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Centimeter) · 2Weight (Gram) · 2Length (Centimeter) · 2Height (Centimeter) · 2

Use these as the dimensions to specify in a tender line.

How many hair growth laser device products are registered in the US?

144 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Hair growth laser device", from 28 companies. The largest labeler is Capillus, Llc with 19% of records.

Which FDA product codes apply?

OAP (Laser, Comb, Hair), ISA (Massager, Therapeutic, Electric), NDP (Accessories, Implant, Dental, Endosseous)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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