Identity
- Trade Name
- Photonica Professional FDA UDI
- Generic Name
- Low-intensity laser fat liquefaction system FDA UDI
- Device Name
- Photonica Professional, Red Light (635 nm) FDA UDI
- Model / Reference
- 60001 FDA UDI
- Description
- Photonica Professional, Red Light (635 nm) FDA UDI
Identifiers
- Catalog Number
- 60001 FDA UDI
- Primary DI / UDI-DI
- 00860925000307 FDA UDI
- FDA Product Code
- OLI FDA UDIGEX FDA UDI
- GMDN Term
- Low-intensity laser fat liquefaction system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5400 FDA UDI878.4810 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
Yes
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: Low-intensity laser fat liquefaction system
Photonica Professional by Photonica USA LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Low-intensity laser fat liquefaction system.
- SculpSure Applicator, Refurbished — Cynosure, LLC · Class II
- Zerona Z6 — Erchonia Corporation · Class II
- Belt Bliss — Venus Concept Inc. · Class II
- Zerona AD — Erchonia Corporation · Class II
- ASSY, MASK FLEX CIRCUIT, MED, SUB — Cynosure, LLC · Class II
- Erchonia Zerona VZ8 — Erchonia Corporation · Class II
- SculpSure Applicator — Cynosure, LLC · Class II
- ASSY, FINAL LASER, SCULPSURE, SUB ONLY — Cynosure, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Photonica USA LLC
Sources (1)
- FDA UDI e7b8d029-d602-4823-b87a-6f09e7cbb322 34 fields · synced May 30, 2026