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GentleYAG 12/15/18 Delivery System W/DCD 7122-00-3409

by Candela Corporation

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817495022321 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
GentleYAG 12/15/18 Delivery System W/DCD
Generic Name
Dermatological laser beam guiding handpiece
Model / Reference
7122-00-3409
Primary DI / UDI-DI
00817495022321
510(k) Number
FDA Product Code
GEX
GMDN Term
Dermatological laser beam guiding handpiece
Device Class
Class II
Regulation Number
878.4810
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K140122)

Show all (12)

Other devices from Candela Corporation

See all devices from Candela Corporation →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No