Air Gap Fiber

510(k) Number

K232106 ↗

FDA product code

GEX

FDA applicant

Wontech Co., Ltd.

Device class

Class II

Regulation

21 CFR Part 878.4810

Advisory committee

General, Plastic Surgery

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

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

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• FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS by Fotona D.D.
• CARBON DIOXIDE LASER SYSTEMS W/ARTHOGUIDE CO2 DEL. by Heraeus Lasersonics, Inc.
• MODEL MD-45 CO2 LASER FOR DERMATOLOGY/PODIATRY USE by Laser Engineering Heart, Inc.
• ENDOSCOPIC USES OF THE ARGON LASER IN GENERAL SURG by Hgm Medical Laser Systems, Inc.
• TRIO Handpiece by OMNIGUIDE, INC.
• PROLITE PULSED LIGHT SYSTEM by Big Sky Laser Technologies, Inc.
• SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER by SIRONA Dental Systems GmbH
• ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU by Bio Quantum Technologies, Inc.
• PROLITE III TOWER AND PR AND HR HANDPIECE by Quantel S.A.

• Oligio

  Class IIb

  CE/MDD

• Tightan Pro

  Class IIa

  CE/MDR CE/MDD

• NOUVADerm

  Class II

  FDA 510(k) ×2 Active Cleared 25 Aug 2023 GUDID on market

• Air Gap Fiber AG365

  Class II

  FDA 510(k) K232106 Active Cleared 8 Jan 2024 GUDID on market

See all devices from Wontech Co., Ltd →