Identity
- Trade Name
- Forma Light FDA UDI
- Generic Name
- Cosmetic red-light phototherapy system, professional FDA UDI
- Device Name
- System supporting IPL (Intense Pulsed Light) applicators for various treatments such as Hair Removal, Acne, Pigmented Lesions FDA UDI
- Model / Reference
- FS60000 FDA UDI
- Description
- System supporting IPL (Intense Pulsed Light) applicators for various treatments such as Hair Removal, Acne, Pigmented Lesions FDA UDI
Identifiers
- Catalog Number
- FS60000 FDA UDI
- Primary DI / UDI-DI
- 07290016681017 FDA UDI
- 510(k) Number
- K160195 FDA UDI
- FDA Product Code
- ONF FDA UDI
- GMDN Term
- Cosmetic red-light phototherapy system, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cosmetic red-light phototherapy system, professional
Forma Light by Formatk Systems Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cosmetic red-light phototherapy system, professional.
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- Del Sol Red Light Therapy System — Hydrafacial LLC · Class II
- MTONE EVO — M & T SRL · Class II
- Del Sol Red Light Therapy System — Hydrafacial LLC · Class II
- MT ONE — M & T SRL · Class II
- Kernel — Xuzhou Kernel Medical Equipment Co., Ltd. · Class II
- MT ONE — M & T SRL · Class II
Cleared under the same submission
K160195 also covers:
- B-HR — FORMATK SYSTEMS LTD
- B-HR* — FORMATK SYSTEMS LTD
- B-SR — FORMATK SYSTEMS LTD
- F-AC — FORMATK SYSTEMS LTD
- F-HR — FORMATK SYSTEMS LTD
- F-HR* — FORMATK SYSTEMS LTD
- F-SR — FORMATK SYSTEMS LTD
- Forma — FORMATK SYSTEMS LTD
- Forma Cart — FORMATK SYSTEMS LTD
- HR — FORMATK SYSTEMS LTD
- HR* — FORMATK SYSTEMS LTD
- PLG — FORMATK SYSTEMS LTD
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
- Formatk Systems Ltd
Sources (1)
- FDA UDI 70197ce5-c5b7-4132-8542-c9c8d16e1e2b 35 fields · synced Jun 8, 2026