Identity
- Trade Name
- Laser Hair Growth Cap FDA UDI
- Generic Name
- Hair growth laser device FDA UDI
- Device Name
- Laser Hair Growth Cap is a dome-shaped low level laser therapy (LLLT) device designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of laser diodes. FDA UDI
- Model / Reference
- 1.0 FDA UDI
- Description
- Laser Hair Growth Cap is a dome-shaped low level laser therapy (LLLT) device designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of laser diodes. FDA UDI
Identifiers
- Catalog Number
- D549215 FDA UDI
- Primary DI / UDI-DI
- G680TW147 FDA UDI
- 510(k) Number
- K192627 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hair growth laser device
Laser Hair Growth Cap by Blissco Medical Device Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hair growth laser device.
- Capillus — Capillus, LLC · Class II
- Xtrallux™ — Xtrallux, LLC · Class II
- Diode Laser Cap — Cosmo Far East Technology Limited · Class II
- Hair Boom69, Hair Boom — WONTECH CO., LTD · Class II
- HairMax — Lexington International, LLC · Class II
- RedRestore — 10589578 Canada Inc. · Class II
- Hairmax — Lexington International, LLC · Class II
- HairMax — Lexington International, LLC · Class II
Cleared under the same submission
K192627 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
- Blissco Medical Device Limited
Sources (1)
- FDA UDI 456a822b-5882-40b4-a299-4cad2769d760 36 fields · synced May 30, 2026