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Epy-50

by Ddc Technologies, Inc.

Epy-50 is a Class II device made by Ddc Technologies, Inc., cleared under FDA 510(k) K020513 on 16 May 2002 and listed in FDA GUDID since 9 Dec 2019 (UDI-DI 00860002307039), active as of 22 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 22 Oct 2026

Documents

510(k) K020513

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860002307039 UDI-DI Date9 Dec 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK020513 Date16 May 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K020513 decided 16 May 2002 Active
  • FDA GUDID UDI-DI 00860002307039 listed 9 Dec 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K020513
  2. Listed FDA GUDID 00860002307039

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Dermatological solid-state laser system
Model / Ref / Catalog
EPY-50
Primary DI / UDI-DI
00860002307039
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

Similar devices in this category

Other devices filed under Dermatological solid-state laser system.

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Properties

  • Prescription use
Other properties (14, all answered No)