Cleared Traditional

K960636 - LASERSONICS ND:YAG CYLINDRICALLY DIFFUSING STERILE DISPOSABLE FIBER

K960636 is an FDA 510(k) clearance for LASERSONICS ND:YAG CYLINDRICALLY DIFFUS..., manufactured by Heraeus Surgical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K960636 · Heraeus Surgical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
189d
Days
Class 2
Risk

K960636 is an FDA 510(k) clearance for the LASERSONICS ND:YAG CYLINDRICALLY DIFFUSING STERILE DISPOSABLE FIBER. 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 Heraeus Surgical, Inc. (Milpitas, US). The FDA issued a Cleared decision on August 21, 1996 after a review of 189 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 Heraeus Surgical, Inc. devices

FDA 510(k) Submission Details - K960636

510(k) Number K960636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1996
Decision Date August 21, 1996
Days to Decision 189 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
74d slower than avg
Panel avg: 115d · This submission: 189d
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 2268
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K960636.
MEDLITE/755 ALEXANDRITE LASER SYSTEM
K961006 · Continuum Biomedical, Inc. · Sep 1996
DIOMED 15, 30, 60 SURGICAL DIODE LASER
K962354 · Lifestream Int'L, Inc. · Sep 1996
SURESCAN
K962242 · Clinicon Corp. · Sep 1996
SHARPLAN LASERS, INC. AF ACUSPOT MICROMANIPULATOR (713)
K962974 · Sharplan Lasers, Inc. · Aug 1996
ARGON CURING LASER
K961682 · Premier Laser Systems, Inc. · Aug 1996
MEDLITE/ERBIUM LASER SYSTEM
K961748 · Continuum Biomedical, Inc. · Jul 1996