Identity
- Trade Name
- HR-Mini FDA UDI
- Generic Name
- Dermatological laser beam guiding handpiece FDA UDI
- Device Name
- Laser Applicator to be used with Formatk Systems Ltd supporting systems for Hair Removal treatments FDA UDI
- Model / Reference
- FS80021 FDA UDI
- Description
- Laser Applicator to be used with Formatk Systems Ltd supporting systems for Hair Removal treatments FDA UDI
Identifiers
- Catalog Number
- FS80021 FDA UDI
- Primary DI / UDI-DI
- 07290016681437 FDA UDI
- 510(k) Number
- K162781 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological laser beam guiding handpiece 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
No
FDA UDI
Category: Dermatological laser beam guiding handpiece
HR-Mini by Formatk Systems Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dermatological laser beam guiding handpiece.
- GentleYAG 1.5/3MM Delivery System W/DCD — Candela Corporation · Class II
- Clear & Brilliant — Solta Medical, Inc. · Class II
- hydrosun 750 — Hydrosun Medizintechnik GmbH · Class IIa
- GentleYAG 3MM Delivery System W/O DCD — Candela Corporation · Class II
- External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima — Candela Corporation · Class II
- TL 30 — Globalcare Medical Technology Co., Ltd. · Class IIa
- Open — Candela Corporation · Class II
- HydraFacial — Hydrafacial LLC · Class I
Cleared under the same submission
K162781 also covers:
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
- Formatk Systems Ltd
Sources (1)
- FDA UDI 48da0bbd-28d0-4057-95f8-9dacae819d3a 35 fields · synced May 30, 2026