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510(k) K875314

GL-35 COLPOSCOPIC LASER SYSTEM by Laser Engineering, Inc. — Product Code HHR

K875314 is an FDA 510(k) premarket notification submitted by Laser Engineering, Inc. for the device "GL-35 COLPOSCOPIC LASER SYSTEM". The FDA issued a decision of Substantially Equivalent on August 5, 1988. The device falls under product code HHR (Laser, Surgical, Gynecologic), a Class II device regulated under 21 CFR 884.4550. Laser Engineering, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1988
Date Received
December 29, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Surgical, Gynecologic
Device Class
Class II
Regulation Number
884.4550
Review Panel
OB
Submission Type

Other clearances by Laser Engineering, Inc.

  • K211605 — Dual Switch (September 22, 2022)
  • 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)
  • K881581 — MODEL MD-45 CO2 LASER FOR OB-GYN & UROLOGICAL USE (June 3, 1988)
  • K881586 — MODEL MD-45 CO2 LASER FOR ENT APPLICATIONS (June 3, 1988)

Other clearances for product code HHR

  • K881507 — ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES (April 27, 1989)
  • K871875 — MODEL 5050 SURGILASER FOR OB-GYN USE (August 22, 1988)
  • K874615 — LASER CANNISTER FILTER (June 23, 1988)
  • K880591 — LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE (June 1, 1988)
  • K880930 — MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE (May 31, 1988)
  • K880991 — LASER OPTICAL CATHETER SYSTEM (May 25, 1988)
  • K880173 — MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION (March 24, 1988)
  • K874837 — KTP/532 LASER FOR OB-GYN USE (March 14, 1988)
  • K875078 — HERACURE LS 500 (February 22, 1988)
  • K870841 — MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN (February 2, 1988)

FDA data resources