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Frax Pro 9SYS7852-001-CNDL

by Candela Corporation

Ref Frax Pro System / 9SYS7852-001-CNDLModel 9SYS7852-001-CNDL

Frax Pro 9SYS7852-001-CNDL is a device classified as Class IIb in the EU and Class II in the US made by Candela Corporation, registered in EUDAMED on 8 May 2026 (Basic UDI-DI B-00817495023465) and listed in FDA GUDID since 15 Jan 2021 (UDI-DI 00817495023465), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00817495023465 Basic UDI-DI 00817495023465UDI-DIDate8 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817495023465 UDI-DI Date15 Jan 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00817495023465 registered 8 May 2026 Active
  • FDA GUDID UDI-DI 00817495023465 listed 15 Jan 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00817495023465
  2. Registered EUDAMED B-00817495023465

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Frax Pro
Generic name
Multi-modality skin surface treatment system generator
Device name
Frax Pro Laser System
Model / reference
9SYS7852-001-CNDL, Frax Pro System / 9SYS7852-001-CNDL
Primary DI / UDI-DI
00817495023465
Basic UDI-DI
B-00817495023465
FDA product code
GEX
EMDN code
Z12011019 Multi–platform laser
GMDN term
Multi-modality skin surface treatment system generator
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4810
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
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

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Multi-modality skin surface treatment system generator

Similar devices in this category

Other devices filed under MULTI–PLATFORM LASER.

Other devices from Candela Corporation

See all devices from Candela Corporation →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)