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EpilMe System 300-1601

by Neauvia North America, Inc

EpilMe System 300-1601 is a Class II device made by Neauvia North America, Inc, cleared under FDA 510(k) K213261 on 2 Jun 2022 and listed in FDA GUDID since 3 Oct 2022 (UDI-DI 00850017374201), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K213261

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850017374201 UDI-DI Date3 Oct 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK213261 Date2 Jun 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K213261 decided 2 Jun 2022 Active
  • FDA GUDID UDI-DI 00850017374201 listed 3 Oct 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K213261
  2. Listed FDA GUDID 00850017374201

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EpilMe System
Generic name
Dermatological solid-state laser system
Model / reference
300-1601
Primary DI / UDI-DI
00850017374201
510(k) Number
FDA product code
GEX
GMDN term
Dermatological solid-state laser system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dermatological solid-state laser system

Similar devices in this category

Other devices filed under Dermatological solid-state laser system.

Other devices from Neauvia North America, Inc

See all devices from Neauvia North America, Inc →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)