Identity
- Trade Name
- Capillus FDA UDI
- Generic Name
- Red/blue light phototherapy unit FDA UDI
- Device Name
- Red and blue light therapy device to reduce the appearance of fine lines and wrinkles and treat mild to moderate acne vulgaris. FDA UDI
- Model / Reference
- AST-804 FDA UDI
- Description
- Red and blue light therapy device to reduce the appearance of fine lines and wrinkles and treat mild to moderate acne vulgaris. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810045461427 FDA UDI
- 510(k) Number
- K213056 FDA UDI
- FDA Product Code
- OHS FDA UDIOLP FDA UDI
- GMDN Term
- Red/blue light phototherapy unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Capillus by Capillus, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Capillus, LLC
Sources (1)
- FDA UDI 160ef4c5-76dd-4e49-b0fb-b4d1441826f3 35 fields · synced May 29, 2026