Cleared Traditional

K000023 - FRIENDLY LIGHT ER:YAG PULSED LASER

K000023 is an FDA 510(k) clearance for FRIENDLY LIGHT ER:YAG PULSED LASER, manufactured by Innotech USA, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K000023 · Innotech USA, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Nov 2000
Decision
307d
Days
Class 2
Risk

K000023 is an FDA 510(k) clearance for the FRIENDLY LIGHT ER:YAG PULSED LASER. 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 Innotech USA, Inc. (Princeton, US). The FDA issued a Cleared decision on November 6, 2000 after a review of 307 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Innotech USA, Inc. devices

FDA 510(k) Submission Details - K000023

510(k) Number K000023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2000
Decision Date November 06, 2000
Days to Decision 307 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
192d slower than avg
Panel avg: 115d · This submission: 307d
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 2067
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K000023.
PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES
K002884 · Fotona D.D. · Dec 2000
IMAGE VASCULAR LASER
K003046 · Sciton, Inc · Nov 2000
ARAMIS DERMATOLOGICAL LASER
K002649 · Palomar Medical Technologies, Inc. · Nov 2000
CANDELA MID IR DIODE LASER SYSTEM
K002421 · Candela Corp. · Nov 2000
OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A
K001676 · Trimedyne, Inc. · Nov 2000
CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15
K002296 · Ceram Optec, Inc. · Oct 2000