810nm 16W (80x200mW) - Giant Laser Cluster
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Giant Laser Cluster Probe. 810nm/16W Infra-red laser cluster. EUDAMED810nm 16W (80x200mW) - Giant Laser Cluster FDA UDI
- Generic Name
- Red-light phototherapy unit, professional FDA UDI
- Device Name
- Giant Laser Cluster Probe. 810nm/16W Infra-red laser cluster. EUDAMEDS2195 810nm 16W (80x200mW) - Giant Laser Cluster FDA UDI
- Model / Reference
- S2195 EUDAMED2.3 FDA UDI
- Description
- S2195 810nm 16W (80x200mW) - Giant Laser Cluster FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060494130459 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060494130459 EUDAMED
- 510(k) Number
- K033923 FDA UDI
- FDA Product Code
- ILY FDA UDI
- EMDN Code
- Z12040202 PHOTOTHERAPY EQUIPMENT EUDAMED
- GMDN Term
- Red-light phototherapy unit, professional FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5500 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Red-light phototherapy unit, professional
810nm 16W (80x200mW) - Giant Laser Cluster by Thor Photomedicine Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — 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 (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Thor Photomedicine Inc.
Sources (2)
- FDA UDI 18519ce7-75ee-48e2-bd46-7c02e23ab1bd 34 fields · synced Jul 24, 2026
- EUDAMED 72556075-8bd6-4eb8-b0f4-2297f16d7735 61 fields · synced Jul 24, 2026