Cleared Traditional

K963094 - CYNOSURE PHOTOGENICA LP DERMATOLOGICAL ...

K963094 is the FDA 510(k) clearance for CYNOSURE PHOTOGENICA LP DERMATOLOGICAL ... by Cynosure, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K963094 · Cynosure, Inc. · General & Plastic Surgery device
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Dec 1996
Decision
130d
Days
Class 2
Risk

K963094 is an FDA 510(k) clearance for the CYNOSURE PHOTOGENICA LP DERMATOLOGICAL VASCULAR LESION LASER. 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 Cynosure, Inc. (Bedford, US). The FDA issued a Cleared decision on December 16, 1996 after a review of 130 days - within the typical 510(k) review window.

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 Cynosure, Inc. devices

Submission Details

510(k) Number K963094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1996
Decision Date December 16, 1996
Days to Decision 130 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 115d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 986
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K963094.
PARASCAN SCANNING DEVICE
K964520 · Laserscope · Feb 1997
OMNIPULSE/OMNIPULSE-MAX
K962632 · Trimedyne, Inc. · Jan 1997
LASERSCOPE ERBIUM
K964076 · Laserscope · Jan 1997
SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS
K963229 · Sharplan Lasers, Inc. · Nov 1996
SHARPLAN LASERS, INC. SILKTOUCH CO2 FLASH SCANNER
K961935 · Sharplan Lasers, Inc. · Nov 1996
CYNOSURE PHOTOAPPEAL CO2 SURGICAL LASERS
K962993 · Cynosure, Inc. · Oct 1996