Identity
- Trade Name
- CURE LaserCap FDA UDI
- Generic Name
- Hair growth laser device FDA UDI
- Device Name
- CURE LaserCap FDA UDI
- Model / Reference
- 00850056575140 FDA UDI
- Description
- CURE LaserCap FDA UDI
Identifiers
- Catalog Number
- 00850056575140 FDA UDI
- Primary DI / UDI-DI
- 00850056575140 FDA UDI
- 510(k) Number
- K203826 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hair growth laser device
CURE LaserCap by LaserCap Company — 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
K203826 also covers:
- Foundation Light Therapy LaserCap — LaserCap Company
- Foundation Light Therapy Optima LaserCap — LaserCap Company
- Get Hair MD LaserCap — LaserCap Company
- LaserCap HD — LaserCap Company
- LaserCap HD XL — LaserCap Company
- LaserCap HD+ — LaserCap Company
- LaserCap MC2 — LaserCap Company
- LaserCap SD — LaserCap Company
- Maxim LaserCap — LaserCap Company
- Medi Tresse LaserCap HD — LaserCap Company
- Medi Tresse LaserCap HD+ — LaserCap Company
- Turbo LaserCap — LaserCap Company
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- LaserCap Company
Sources (1)
- FDA UDI 44802d0a-558d-4569-9387-76b06f83b46a 37 fields · synced May 30, 2026