Infraguide(Tm)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K875115 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Model Ls 840, CO2 Laser

  Class II

  FDA 510(k) K864563 Active Cleared 9 Apr 1987

• Argon/Krypton Laser System 8500

  Class II

  FDA 510(k) K844209 Active Cleared 6 Feb 1985

• Model Hse-5M Microwave Surgery Equipment/Microtaze

  Class II

  FDA 510(k) K864413 Active Cleared 9 Dec 1986

• Lasersonics Laser Cystoscope Model Fcy-6-35

  Class II

  FDA 510(k) K860822 Active Cleared 17 Apr 1986

• 870 Surgical Sys Control Pulse Modification

  Class II

  FDA 510(k) K852252 Active Cleared 27 Jun 1985

• Model 4900 Nd:yag Laser for Gastro & Genitour Appl

  Class II

  FDA 510(k) K880171 Active Cleared 11 Apr 1988

See all devices from Cooper Lasersonics, Inc. →