Cleared Traditional

K870517 - 0.1MM

K870517 is the FDA 510(k) clearance for 0.1MM by Coherent Medical Group. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K870517 · Coherent Medical Group · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1987
Decision
64d
Days
Class 2
Risk

K870517 is an FDA 510(k) clearance for the 0.1MM, 0.25MM, 0.5MM, ZOOM DERMATOLOGIC HANDPIECE. 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 Coherent Medical Group (Palo Alto, US). The FDA issued a Cleared decision on April 10, 1987 after a review of 64 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Coherent Medical Group devices

Submission Details

510(k) Number K870517 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 05, 1987
Decision Date April 10, 1987
Days to Decision 64 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
51d faster than avg
Panel avg: 115d · This submission: 64d
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 1184
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K870517.
MODEL 10-C W/ SA-10A/U OPTICAL ATTACHMENT/SURG USE
K870838 · Directed Energy, Inc. · May 1987
MODEL 10-C WITH AN SA-10B/U OPTICAL ATTACHMENT
K870970 · Directed Energy, Inc. · May 1987
MODEL 20-C WITH AN SA-20B/U OPTICAL ATTACHMENT
K870971 · Directed Energy, Inc. · May 1987
MODEL LS 860, CO2 LASER
K864562 · Cooper Lasersonics, Inc. · Apr 1987
MODEL LS 840, CO2 LASER
K864563 · Cooper Lasersonics, Inc. · Apr 1987
OMNIPLUS FREQ DOUBLE ND:YAG PHOTOSURG SYS/NEURO
K862514 · Laserscope · Feb 1987