Identity
- Trade Name
- Photofrin® 630 PDT Laser FDA UDI
- Generic Name
- Oncological diode laser system FDA UDI
- Device Name
- 630 nm Photodynamic Therapy Laser FDA UDI
- Model / Reference
- BWF5-630-2-PIN FDA UDI
- Description
- 630 nm Photodynamic Therapy Laser FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00376128000193 FDA UDI
- PMA Number
- P990021 FDA UDI
- FDA Product Code
- MVF FDA UDI
- GMDN Term
- Oncological diode laser system FDA UDI
Classification
- Device Class
- Class III 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Oncological diode laser system
Photofrin® 630 PDT Laser by Pinnacle Biologics, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oncological diode laser system.
- Photofrin® 630 PDT Laser — PINNACLE BIOLOGICS, INC. · Class III
- Photofrin® 630 PDT Laser — PINNACLE BIOLOGICS, INC. · Class III
Cleared under the same submission
P990021 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 III | Pending data |
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Manufacturer
- Manufacturer
- Pinnacle Biologics, Inc.
Sources (1)
- FDA UDI ab1a63d9-b93e-4a50-bf7e-6bbe4a710d02 35 fields · synced May 30, 2026