Identity
- Trade Name
- LED Helmet FDA UDI
- Generic Name
- Red-light phototherapy unit, professional FDA UDI
- Device Name
- S2185 LED Helmet FDA UDI
- Model / Reference
- 2.3 FDA UDI
- Description
- S2185 LED Helmet FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060494130589 FDA UDI
- 510(k) Number
- K033923 FDA UDI
- FDA Product Code
- ILY FDA UDI
- GMDN Term
- Red-light phototherapy unit, professional 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Red-light phototherapy unit, professional
LED Helmet by Thor Photomedicine Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K033923 also covers:
- 104 LED Cluster Probe 660nm & 850nm 2W — THOR PHOTOMEDICINE INC.
- 104 LED Cluster Probe 660nm & 850nm 2W — THOR PHOTOMEDICINE INC.
- 104 LED Cluster Probe PRX100 660nm & 850nm — THOR PHOTOMEDICINE INC.
- 104 LED Cluster issue 3 — THOR PHOTOMEDICINE INC.
- 19 LED Cluster Probe 660nm & 850nm 370mW — THOR PHOTOMEDICINE INC.
- 19 LED Cluster issue 3 — THOR PHOTOMEDICINE INC.
- 660nm 100mW Acu Tip B/G — THOR PHOTOMEDICINE INC.
- 660nm 200mW Acu Tip B/G — THOR PHOTOMEDICINE INC.
- 660nm 200mW Standard Tip B/G — THOR PHOTOMEDICINE INC.
- 660nm 30mW Acu Tip B/G — THOR PHOTOMEDICINE INC.
- 660nm 30mW Acu Tip B/G — THOR PHOTOMEDICINE INC.
- 660nm 30mW Standard Tip B/G — THOR PHOTOMEDICINE INC.
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
- Thor Photomedicine Inc.
Sources (1)
- FDA UDI 0eb47790-70bc-462c-b1fb-fe58bf1fb014 34 fields · synced May 30, 2026