Identity
- Trade Name
- EpilMe Applicator FDA UDI
- Generic Name
- Dermatological solid-state laser system FDA UDI
- Device Name
- Handpiece applicator for EpilMe System FDA UDI
- Model / Reference
- 300-1701 FDA UDI
- Description
- Handpiece applicator for EpilMe System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850017374218 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological solid-state laser system 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 solid-state laser system
EpilMe Applicator by Neauvia North America, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dermatological solid-state laser system.
- CLARITY II — Lutronic Corporation · Class II
- AuraLux — Acclaro Corporation · Class II
- GentleMax Pro — Candela Corporation · Class II
- CLARITY II — Lutronic Corporation · Class II
- GentleYAG — Candela Corporation · Class II
- Splendor X — Bios, Inc. · Class II
- EPY-50 — DDC TECHNOLOGIES, INC. · Class II
- Canister HFC-134a /980g, ALUM, 15 pack — Candela Corporation · Class II
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
- Neauvia North America, Inc
Sources (1)
- FDA UDI 1e825eb6-afb4-42b5-a2f7-1b2a25d30b0b 33 fields · synced May 30, 2026