Cleared Traditional

K030181 - INTERNATIONAL BIOPHYSICS CORPORATION (I...

K030181 is an FDA 510(k) clearance for INTERNATIONAL BIOPHYSICS CORPORATION (I..., manufactured by International Biophysics Corp.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K030181 · International Biophysics Corp. · General & Plastic Surgery device
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Apr 2003
Decision
90d
Days
Class 2
Risk

K030181 is an FDA 510(k) clearance for the INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM. 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 International Biophysics Corp. (Austin, US). The FDA issued a Cleared decision on April 17, 2003 after a review of 90 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.

View all International Biophysics Corp. devices

FDA 510(k) Submission Details - K030181

510(k) Number K030181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2003
Decision Date April 17, 2003
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
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 1680
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K030181.
COOLTOUCH ND: YAG LASER SYSTEM
K030453 · New Star Lasers, Inc. · May 2003
SMARTXIDE
K031224 · Cynosure, Inc. · May 2003
ARAMIS II DERMATOLOGICAL LASER
K023734 · Quantel Medical · May 2003
LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS
K030147 · Lumenis, Ltd. · Apr 2003
POLRIS LV
K030186 · Syneron Medical, Ltd. · Apr 2003
CANDELA GENTLE LASE FAMILY OF LASER SYSTEM
K024371 · Candela Corp. · Mar 2003