Cleared Traditional

K952489 - 6 WATT HOLMIUM LASER SYSTEM

K952489 is an FDA 510(k) clearance for 6 WATT HOLMIUM LASER SYSTEM, manufactured by New Star Lasers, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K952489 · New Star Lasers, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
237d
Days
Class 2
Risk

K952489 is an FDA 510(k) clearance for the 6 WATT HOLMIUM LASER 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 New Star Lasers, Inc. (Concord, US). The FDA issued a Cleared decision on January 22, 1996 after a review of 237 days - an extended review 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: 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 New Star Lasers, Inc. devices

FDA 510(k) Submission Details - K952489

510(k) Number K952489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1995
Decision Date January 22, 1996
Days to Decision 237 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
122d slower than avg
Panel avg: 115d · This submission: 237d
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 1763
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K952489.
SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM (MODIFICATION)
K954727 · Surgical Laser Technologies, Inc. · Feb 1996
CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE
K954934 · Candela Laser Corp. · Feb 1996
ACCUSCAN MODEL C CO2 LASER SCANNER
K953670 · Reliant Technologies, Inc. · Jan 1996
CERALAS G FREQUENCY DOUBLED ND
K954834 · Ceram Optec, Inc. · Jan 1996
ECLIPSE 2100
K955006 · Cardiogenes · Jan 1996
ODYSSEY HO:YAG SURGICAL LASER SYSTEMS & ACCESSORIES
K951910 · Xintec Corporation · Dec 1995