Identity
- Trade Name
- EndyMed PRO MAX, System, 110V FDA UDI
- Generic Name
- Radio-frequency skin surface treatment/fat liquefaction system control unit FDA UDI
- Device Name
- The EndyMed PRO MAX System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non- invasive treatment of mild to moderate facial wrinkles and rhytides FDA UDI
- Model / Reference
- Pro Max System 110V white FDA UDI
- Description
- The EndyMed PRO MAX System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non- invasive treatment of mild to moderate facial wrinkles and rhytides FDA UDI
Identifiers
- Catalog Number
- ND_PRD00464-00 FDA UDI
- Primary DI / UDI-DI
- 07290016814408 FDA UDI
- 510(k) Number
- K083461 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Radio-frequency skin surface treatment/fat liquefaction system control unit 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
Yes
FDA UDI
EndyMed PRO MAX, System, 110V 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 |
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Manufacturer
- Manufacturer
- Endymed Medical Ltd
Sources (1)
- FDA UDI 6d56acfd-476a-4df7-a421-be00673dd758 37 fields · synced Jun 1, 2026