510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K875314Substantially Equivalent

Gl-35 Colposcopic Laser System

Laser Engineering, Inc., Milford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K875314 is the FDA 510(k) clearance record for GL-35 COLPOSCOPIC LASER SYSTEM, a class II device, cleared for Laser Engineering, Inc. on under FDA product code HHR (Laser, Surgical, Gynecologic). FDA records list 18 510(k) clearances for Laser Engineering, Inc., from to . As of , FDA records show no recalls naming K875314.

Clearance record

Decision date
Received
(220 days to decision)
Product code
HHR Laser, Surgical, Gynecologic
Regulation
21 CFR 884.4550
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Laser Engineering, Inc. 113 Cedar St., Milford MA
Third party review
No

Clearances, product code HHR

Trailing 12 months

FDA records hold no clearances under product code HHR in the trailing twelve months.

FDA records show no clearances under product code HHR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HHR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260