Identity
- Trade Name
- ST FDA UDI
- Generic Name
- Radio-frequency skin contouring system applicator, bipolar FDA UDI
- Device Name
- Radiofrequency Applicator to be used with Formatk Systems Ltd supporting systems for minor muscle aches and pain treatments FDA UDI
- Model / Reference
- FS10011 FDA UDI
- Description
- Radiofrequency Applicator to be used with Formatk Systems Ltd supporting systems for minor muscle aches and pain treatments FDA UDI
Identifiers
- Catalog Number
- FS10011 FDA UDI
- Primary DI / UDI-DI
- 07290016681277 FDA UDI
- 510(k) Number
- K160195 FDA UDI
- FDA Product Code
- PBX FDA UDI
- GMDN Term
- Radio-frequency skin contouring system applicator, bipolar FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
No
FDA UDI
Category: Radio-frequency skin contouring system applicator, bipolar
St by Formatk Systems Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radio-frequency skin contouring system applicator, bipolar.
- LF2 applicator — Venus Concept Inc. · Class II
- Diamondpolar applicator — Venus Concept Inc. · Class II
- LB2 + LF2 kit — Venus Concept Inc. · Class II
- Venus Viva applicator — Venus Concept Inc. · Class II
- Venus Freeze applicators kit — Venus Concept Inc. · Class II
- Octipolar applicator — Venus Concept Inc. · Class II
- Diamondpolar applicator for Venus Freeze — Venus Concept Inc. · Class II
- Venus Viva applicator — Venus Concept Inc. · 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
- Forma Light — FORMATK SYSTEMS LTD
- HR — FORMATK SYSTEMS LTD
- HR* — 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 0a7abea0-d7a5-473d-a9e6-f1f4266ddf9d 35 fields · synced Jun 1, 2026