Cleared Traditional

K901021 - F300 SERIES CONTACT FIBER HANDPIECES

K901021 is an FDA 510(k) clearance for F300 SERIES CONTACT FIBER HANDPIECES, manufactured by Hgm Medical Laser Systems, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K901021 · Hgm Medical Laser Systems, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1990
Decision
39d
Days
Class 2
Risk

K901021 is an FDA 510(k) clearance for the F300 SERIES CONTACT FIBER HANDPIECES. 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 Hgm Medical Laser Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on April 13, 1990 after a review of 39 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 Hgm Medical Laser Systems, Inc. devices

FDA 510(k) Submission Details - K901021

510(k) Number K901021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1990
Decision Date April 13, 1990
Days to Decision 39 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
76d faster than avg
Panel avg: 115d · This submission: 39d
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 1459
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K901021.
KTP/532 (TM) SURGICAL LASER
K901943 · Laserscope · May 1990
MODELS 4000/4900/6000/8000/8900, LUXAS&1700 ND:YAG
K900630 · Heraeus Lasersonics, Inc. · May 1990
HERAEUS LASERSONICS CO2 WAVEGUIDE DELIVERY SYSTEM
K900751 · Heraeus Lasersonics, Inc. · May 1990
LASER LAPAROSCOPIC CHOLECYSTECTOMY
K901541 · Surgical Laser Technologies, Inc. · Apr 1990
SHARPLAN ND:YAG LASERS FOR ENT AND NECK SURGERY
K900345 · Sharplan Lasers, Inc. · Apr 1990
KTP/532 SURGICAL LASER SYSTEM W/KTP/YAG MODULE
K895945 · Laserscope · Apr 1990