Cleared Traditional

K954195 - INDIGO PORTABLE LASER SYSTEM, INDDIGO FIBEROPTICS

K954195 is an FDA 510(k) clearance for INDIGO PORTABLE LASER SYSTEM, manufactured by Indigo Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K954195 · Indigo Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
141d
Days
Class 2
Risk

K954195 is an FDA 510(k) clearance for the INDIGO PORTABLE LASER SYSTEM, INDDIGO FIBEROPTICS. 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 Indigo Medical, Inc. (Palo Alto, US). The FDA issued a Cleared decision on January 25, 1996 after a review of 141 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K954195

510(k) Number K954195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1995
Decision Date January 25, 1996
Days to Decision 141 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 115d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEX Device Classification - Class 2, Special Controls

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 2835
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K954195.
APPLIED OPTRONICS MODEL AOC 5060 SURGFICAL DIODE LASER SYSTEM
K955007 · Applied Optronics Corp. · Jan 1996
APPLIED OPTRONICS MODEL AOC 25 SURGICAL DIODE
K955014 · Applied Optronics Corp. · Jan 1996
MICROQUARTZ MEDICAL TYPE B SIDE-FIRING LASER FIBER
K955861 · Microquartz Medical, Inc. · Jan 1996
OMEGA ULTRASCAN
K954911 · Gyne-Tech Instrument Corp. · Jan 1996
6 WATT HOLMIUM LASER SYSTEM
K952489 · New Star Lasers, Inc. · Jan 1996
MICROQUARTZ MEDICAL GENERAL SHAPE LASER FIBER
K954904 · Microquartz Medical, Inc. · Jan 1996
K954195 · INDIGO PORTABLE LASER SYSTEM, INDDIGO FIBEROPTICS
Download PDF FDA Summary Indigo Medical, Inc.