Cleared Traditional

K901638 - MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33

K901638 is an FDA 510(k) clearance for MODIFIED COMBOLASER 5050 & NEW MODEL 50..., manufactured by Lasermatic, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K901638 · Lasermatic, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1990
Decision
79d
Days
Class 2
Risk

K901638 is an FDA 510(k) clearance for the MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33. 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 Lasermatic, Inc. (Attleboro, US). The FDA issued a Cleared decision on June 27, 1990 after a review of 79 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lasermatic, Inc. devices

FDA 510(k) Submission Details - K901638

510(k) Number K901638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1990
Decision Date June 27, 1990
Days to Decision 79 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
36d faster than avg
Panel avg: 115d · This submission: 79d
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 2362
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K901638.
MODELS 4000,4900,6000,8000,8900,LUXUS 60,100,1700
K902148 · Heraeus Lasersonics, Inc. · Jul 1990
ADD'L USE OF THE KTP/YAG SURGICAL LASER
K902058 · Laserscope · Jun 1990
SURGILASE YAG 100 SURGICAL LASER SYSTEM
K902211 · Surgilase, Inc. · Jun 1990
MODEL YC-1200/PHOTOCOAGULATOR OPHTHALMIC LASER
K901481 · Nidek, Inc. · Jun 1990
MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENT
K894241 · Directed Energy, Inc. · Jun 1990
KTP/532 (TM) SURGICAL LASER
K901943 · Laserscope · May 1990