Identity
- Trade Name
- Forma FDA UDI
- Generic Name
- Multi-modality skin surface treatment system FDA UDI
- Device Name
- Multi-modality system supporting IPL (Intense Pulsed Light), RF (Radio Frequency) and Diamond Peeling applicators for various treatments such as Hair Removal, Acne, Pigmented Lesions, Skin Dermabrasion FDA UDI
- Model / Reference
- FS10000 FDA UDI
- Description
- Multi-modality system supporting IPL (Intense Pulsed Light), RF (Radio Frequency) and Diamond Peeling applicators for various treatments such as Hair Removal, Acne, Pigmented Lesions, Skin Dermabrasion FDA UDI
Identifiers
- Catalog Number
- FS10000 FDA UDI
- Primary DI / UDI-DI
- 07290016681000 FDA UDI
- 510(k) Number
- K160195 FDA UDI
- FDA Product Code
- PBX FDA UDIONF FDA UDIILY FDA UDIGFE FDA UDI
- GMDN Term
- Multi-modality skin surface treatment system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI878.4810 FDA UDI890.5500 FDA UDI878.4820 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: Multi-modality skin surface treatment system
Forma by Formatk Systems Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multi-modality skin surface treatment system.
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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 Cart — FORMATK SYSTEMS LTD
- Forma Light — 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 4baad1e3-c53c-404d-b1f3-ee8ef05c9ba1 35 fields · synced May 30, 2026