Diode Laser Cap

FDA UDI

Class II (US FDA UDI)

by Cosmo Far East Technology Limited

Identity

Trade Name: Diode Laser Cap FDA UDI
Generic Name: Hair growth laser device FDA UDI
Device Name: Diode Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV. FDA UDI
Model / Reference: COSMO-010 FDA UDI
Description: Diode Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV. FDA UDI

Identifiers

Primary DI / UDI-DI: 06973416570105 FDA UDI
510(k) Number: K173678 FDA UDI
FDA Product Code: OAP FDA UDI
GMDN Term: Hair growth laser device FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.5500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Hair growth laser device

Diode Laser Cap by Cosmo Far East Technology Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Hairmax — Lexington International, LLC · Class II
HairMax — Lexington International, LLC · Class II
HairMax — Lexington International, LLC · Class II

Cleared under the same submission

K173678 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Cosmo Far East Technology Limited

Sources (1)

FDA UDI fc894852-4847-4f6a-9d82-f6a41a3b6f37 35 fields · synced May 30, 2026