Skip to content

GentleMax Pro Plus Medium ACC HP

by Candela Corporation

Ref 7123-CE-0629

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201111↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00817495023199 Basic UDI-DI 00817495023199UDI-DIDate10 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817495023199 UDI-DI Date17 Jan 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK201111 Date26 May 2020IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDD Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
GentleMax Pro Plus Medium ACC HP EUDAMED
GMPP ACC Medium Spot Option Kit, w/Fiber Assembly GUDID
Acc Hand Piece, Medium Spot, Gmpp GUDID
Generic Name
Dermatological laser beam producing handpiece
Model / Ref / Catalog
7123-CE-0629, 7123-CE-0648
Primary DI / UDI-DI
00817495023199, 00817495023144
Basic UDI-DI
B-00817495023199
510(k) Number
FDA Product Code
GEX
EMDN Code
Z12011006, Z12011017
GMDN Term
Dermatological laser beam producing handpiece
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4810
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000022750
Authorised representative
AR Experts B.V. NL-AR-000023989

Other devices from Candela Corporation

See all devices from Candela Corporation →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No