510(k) K211605

Dual Switch by Laser Engineering, Inc. — Product Code GEX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 22, 2022
Date Received: May 25, 2021
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Powered Laser Surgical Instrument
Device Class: Class II
Regulation Number: 878.4810
Review Panel: SU
Submission Type

A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology, neurosurgery, orthopedics (soft tissue), dental and oral surgery, and dentistry. The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.

Other clearances by Laser Engineering, Inc.

K141908 — DUAL SWITCH (October 22, 2014)
K924457 — MICROMANIPULATOR (May 7, 1993)
K912247 — UNIVERSAL COUPLER, LAPAROSCOPIC ACCESSORY (November 13, 1991)
K912347 — BIPURE 1000 (September 23, 1991)
K910062 — 02-10,001 (August 16, 1991)
K911852 — COMPULSE CO2 SURGICAL LASER SYS. (June 7, 1991)
K905676 — MD CO2 SURGICAL LASER SYSTEM/GEN. SURGERY AND ORTH (April 22, 1991)
K875314 — GL-35 COLPOSCOPIC LASER SYSTEM (August 5, 1988)
K881583 — MODEL MD-25 CO2 LASER FOR EAR, NOSE & THROAT (June 3, 1988)
K881582 — MODEL MD-45 CO2 LASER FOR DERMATOLOGY/PODIATRY USE (June 3, 1988)

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