Identity
- Trade Name
- HIGHERDOSE FDA UDI
- Generic Name
- Hair growth laser device FDA UDI
- Device Name
- The HIGHERDOSE Red Light Hat is a home wearable light-emiting diode phototherapy device withproven wavelengths of light 650nm+10nm Red light, which are used to treat Androgenetic Alopecia andpromote hair growth in males who have Norwood- Hamilton Classifications of lla - V patterns of hair lossand to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale 1-1to 1-4, 1l-1, ll-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types l - IV. FDA UDI
- Model / Reference
- HG-120K FDA UDI
- Description
- The HIGHERDOSE Red Light Hat is a home wearable light-emiting diode phototherapy device withproven wavelengths of light 650nm+10nm Red light, which are used to treat Androgenetic Alopecia andpromote hair growth in males who have Norwood- Hamilton Classifications of lla - V patterns of hair lossand to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale 1-1to 1-4, 1l-1, ll-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types l - IV. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850049532440 FDA UDI
- 510(k) Number
- K242363 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
No
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
Higherdose by Shenzhen Kaiyan Medical Equipment Co, . Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- HairMax — Lexington International, LLC · Class II
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
- Shenzhen Kaiyan Medical Equipment Co, . Ltd
Sources (1)
- FDA UDI 26c8f3bc-f2ef-45e0-8ab9-acd1feae5fcd 34 fields · synced Jun 6, 2026