Cleared Traditional

K843517 - MINUTEMAN CO2 MICROSURG LASER DERMATOL-

K843517 is an FDA 510(k) clearance for MINUTEMAN CO2 MICROSURG LASER DERMATOL-, manufactured by American Surgical Laser, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GEY cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K843517 · American Surgical Laser, Inc. · General & Plastic Surgery device
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Dec 1984
Decision
93d
Days
Class 1
Risk

K843517 is an FDA 510(k) clearance for the MINUTEMAN CO2 MICROSURG LASER DERMATOL-. Classified as Motor, Surgical Instrument, Ac-powered (product code GEY), Class I - General Controls.

Submitted by American Surgical Laser, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 7, 1984 after a review of 93 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all American Surgical Laser, Inc. devices

FDA 510(k) Submission Details - K843517

510(k) Number K843517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1984
Decision Date December 07, 1984
Days to Decision 93 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
22d faster than avg
Panel avg: 115d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

GEY Device Classification - Class 1, General Controls

Product Code GEY Motor, Surgical Instrument, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GEY Motor, Surgical Instrument, Ac-powered

All 26
Devices cleared under the same product code (GEY) and FDA review panel - the closest regulatory comparables to K843517.
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