Cleared Traditional

K955734 - LASERSONICS PARASCAN DOSIMETER DEVICE

K955734 is an FDA 510(k) clearance for LASERSONICS PARASCAN DOSIMETER DEVICE, 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 57-day FDA review.

K955734 · Heraeus Surgical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
57d
Days
Class 2
Risk

K955734 is an FDA 510(k) clearance for the LASERSONICS PARASCAN DOSIMETER DEVICE. 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 February 13, 1996 after a review of 57 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 Heraeus Surgical, Inc. devices

FDA 510(k) Submission Details - K955734

510(k) Number K955734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1995
Decision Date February 13, 1996
Days to Decision 57 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
58d faster than avg
Panel avg: 115d · This submission: 57d
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 K955734.
MEDLITE LASER SYSTEM
K955131 · Continuum Biomedical, Inc. · Feb 1996
CERALAS F ND:YAG LASER SYSTEM
K953851 · Ceram Optec, Inc. · Feb 1996
INDIGO MEDICAL MODEL IDL 830E
K955758 · Indigo Medical, Inc. · Feb 1996
SCHWARTZ ELECTRO-OPTICES, INC. TRILASE 2100/20 HOLMIUM LASER
K953585 · Schwartz Electro-Optics, Inc. · Feb 1996
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