Cleared Traditional

K871512 - SL-100 ND:YAG LASER FOR GYNECOLOGY USE

K871512 is the FDA 510(k) clearance for SL-100 ND:YAG LASER FOR GYNECOLOGY USE by Medical Energy, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 445-day FDA review.

K871512 · Medical Energy, Inc. · General & Plastic Surgery device
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Jul 1988
Decision
445d
Days
Class 2
Risk

K871512 is an FDA 510(k) clearance for the SL-100 ND:YAG LASER FOR GYNECOLOGY USE. Classified as Powered Laser Surgical Instrument within the GEX classification (a category for powered laser surgical instruments across multiple specialties), Class II - Special Controls.

Submitted by Medical Energy, Inc. (Pensacola, US). The FDA issued a Cleared decision on July 8, 1988 after a review of 445 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - the FDA general and plastic surgery 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Medical Energy, Inc. devices

Submission Details

510(k) Number K871512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1987
Decision Date July 08, 1988
Days to Decision 445 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
330d slower than avg
Panel avg: 115d · This submission: 445d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GEX Powered Laser Surgical Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition 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.
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEX Powered Laser Surgical Instrument

All 737
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K871512.
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