Cleared Traditional

K033251 - THE FRIENDLYLIGHT ND: YAG LASERS

K033251 is an FDA 510(k) clearance for THE FRIENDLYLIGHT ND: YAG LASERS, 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 147-day FDA review.

K033251 · Innotech USA, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
147d
Days
Class 2
Risk

K033251 is an FDA 510(k) clearance for the THE FRIENDLYLIGHT ND: YAG LASERS. 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. (Washington, Dc, US). The FDA issued a Cleared decision on March 2, 2004 after a review of 147 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 - K033251

510(k) Number K033251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2003
Decision Date March 02, 2004
Days to Decision 147 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
32d slower than avg
Panel avg: 115d · This submission: 147d
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 2890
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K033251.
POWERLITE 600 EX SYSTEM
K033933 · Preswede AB · Mar 2004
STARLUX PULSED LIGHT SYSTEM
K033549 · Palomar Medical Products, Inc. · Mar 2004
PROFILE 1320 LASER SYSTEM
K032459 · Sciton, Inc · Mar 2004
LIGHT AGE Q-CLEAR LASER, MODEL 701-1101
K033259 · Light Age, Inc. · Feb 2004
LAD (EPITURE EASYTOUCH), MODEL LAD-08
K033962 · Norwood Abbey , Ltd. · Feb 2004
FEMTEC LASER MICROKERATOME
K033354 · 20/10 Perfect Vision Optische Gerate GmbH · Feb 2004
K033251 · THE FRIENDLYLIGHT ND: YAG LASERS
Download PDF FDA Summary Innotech USA, Inc.