Cleared Traditional

K971737 - CYNOSURE PHOTOGENICA LPIR DERMATOLOGICAL LASER

K971737 is an FDA 510(k) clearance for CYNOSURE PHOTOGENICA LPIR DERMATOLOGICA..., manufactured by Cynosure, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K971737 · Cynosure, Inc. · General & Plastic Surgery device
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Aug 1997
Decision
88d
Days
Class 2
Risk

K971737 is an FDA 510(k) clearance for the CYNOSURE PHOTOGENICA LPIR DERMATOLOGICAL 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 August 8, 1997 after a review of 88 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 Cynosure, Inc. devices

FDA 510(k) Submission Details - K971737

510(k) Number K971737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1997
Decision Date August 08, 1997
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
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 2022
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K971737.
ACCU-PULSE CARBON DIOXIDE LASER SYSTEM
K971830 · Argus Photonics Group · Aug 1997
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K971879 · Continuum Biomedical, Inc. · Aug 1997
SURESCAN
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IMPROVEMENTS TO THE MEHL RUBY LASER
K971814 · Mehl/Biophile Intl., Inc. · Aug 1997
LASER PERIPHERALS HOLMIUM BARE FIBERS
K972272 · Laser Peripherals, LLC · Jul 1997
SHARPLAN ERBIUM: YAG LASER (4020)
K971648 · Sharplan Lasers, Inc. · Jul 1997