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Fraxis Main Unit FRX-C1

by CLASSYS Inc.

Fraxis Main Unit FRX-C1 is a dermatological carbon dioxide laser system (FDA Class II) made by CLASSYS Inc., cleared under FDA 510(k) K172096 on 9 Aug 2017 and listed in FDA GUDID since 30 Oct 2024 (UDI-DI 08800016903966), 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) K172096

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 Number08800016903966 UDI-DI Date30 Oct 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK172096 Date9 Aug 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172096 decided 9 Aug 2017 Active
  • FDA GUDID UDI-DI 08800016903966 listed 30 Oct 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K172096
  2. Listed FDA GUDID 08800016903966

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Fraxis Main Unit
Generic name
Dermatological carbon dioxide laser system
Model / reference
FRX-C1
Primary DI / UDI-DI
08800016903966
510(k) Number
FDA product code
GEX, ONG
GMDN term
Dermatological carbon dioxide laser system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dermatological carbon dioxide laser system

Cleared under the same submission (K172096)

and 2 more cleared under K172096

Similar devices

Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

Other devices from CLASSYS Inc.

See all devices from CLASSYS Inc. →

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (13, all answered No)