Identity
- Trade Name
- EndyMed PRO MAX, iFine MAX Handpiece FDA UDI
- Generic Name
- Multi-modality skin/body contouring system FDA UDI
- Device Name
- The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for mild to moderate facial wrinkles and rhytides FDA UDI
- Model / Reference
- iFine MAX Handpiece FDA UDI
- Description
- The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for mild to moderate facial wrinkles and rhytides FDA UDI
Identifiers
- Catalog Number
- ND_PRD00469-00 FDA UDI
- Primary DI / UDI-DI
- 07290016814446 FDA UDI
- 510(k) Number
- K083461 FDA UDI
- FDA Product Code
- OUH FDA UDIGEI FDA UDI
- GMDN Term
- Multi-modality skin/body contouring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- Not 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
EndyMed PRO MAX, iFine MAX Handpiece by Endymed Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K083461 also covers:
- EndyMed PRO 85W System 110V — ENDYMED MEDICAL LTD
- EndyMed PRO 85W System Body 110V — ENDYMED MEDICAL LTD
- EndyMed PRO 85W System Face 110V — ENDYMED MEDICAL LTD
- EndyMed PRO mini-shaper Handpiece — ENDYMED MEDICAL LTD
- EndyMed Pro Shaper Handpiece — ENDYMED MEDICAL LTD
- EndyMed Pro Small Handpiece — ENDYMED MEDICAL LTD
- EndyMed Pro iFine Handpiece — ENDYMED MEDICAL 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Endymed Medical Ltd
Sources (1)
- FDA UDI 2ebc0968-fd28-4689-954e-0165155fda71 36 fields · synced May 30, 2026