Cleared Traditional

K875314 - GL-35 COLPOSCOPIC LASER SYSTEM

K875314 is an FDA 510(k) clearance for GL-35 COLPOSCOPIC LASER SYSTEM, manufactured by Laser Engineering, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHR cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K875314 · Laser Engineering, Inc. · Obstetrics & Gynecology device
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Aug 1988
Decision
220d
Days
Class 2
Risk

K875314 is an FDA 510(k) clearance for the GL-35 COLPOSCOPIC LASER SYSTEM. Classified as Laser, Surgical, Gynecologic (product code HHR), Class II - Special Controls.

Submitted by Laser Engineering, Inc. (Milford, US). The FDA issued a Cleared decision on August 5, 1988 after a review of 220 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4550 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Laser Engineering, Inc. devices

FDA 510(k) Submission Details - K875314

510(k) Number K875314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1987
Decision Date August 05, 1988
Days to Decision 220 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 160d · This submission: 220d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HHR Device Classification - Class 2, Special Controls

Product Code HHR Laser, Surgical, Gynecologic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HHR Laser, Surgical, Gynecologic

All 20
Devices cleared under the same product code (HHR) and FDA review panel - the closest regulatory comparables to K875314.
LASER OPTICAL CATHETER SYSTEM
K880991 · Medline Industries, Inc. · May 1988
MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION
K880173 · Cooper Lasersonics, Inc. · Mar 1988
KTP/532 LASER FOR OB-GYN USE
K874837 · Laserscope · Mar 1988
MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN
K870841 · Directed Energy, Inc. · Feb 1988
MODEL 20-C, RL-20A/U, OB-10A/U
K872709 · Directed Energy, Inc. · Feb 1988
SLT CONTACT ND:YAG LASER FOR INTRA-ABDOM.&GENITAL
K872254 · Surgical Laser Technologies, Inc. · Dec 1987