Cleared Traditional

K974674 - CYNOSURE PHOTOLIGHT FLASHLAMP SYSTEM

K974674 is an FDA 510(k) clearance for CYNOSURE PHOTOLIGHT FLASHLAMP SYSTEM, 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 135-day FDA review.

K974674 · Cynosure, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
135d
Days
Class 2
Risk

K974674 is an FDA 510(k) clearance for the CYNOSURE PHOTOLIGHT FLASHLAMP 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 Cynosure, Inc. (Chelmsford, US). The FDA issued a Cleared decision on April 29, 1998 after a review of 135 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

FDA 510(k) Submission Details - K974674

510(k) Number K974674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1997
Decision Date April 29, 1998
Days to Decision 135 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
20d slower than avg
Panel avg: 115d · This submission: 135d
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 K974674.
SOFTLIGHT Q-SWITCHED (ND:YAG) LASER
K971207 · Thermolase Corp. · May 1998
NIDEK PRIMA MODEL GYC-1500/2000
K980547 · Nidek, Inc. · May 1998
LIGHTSHEER
K980420 · Palomar Medical Products, Inc. · May 1998
SURETOUCH
K980784 · Sahar Technologies, Inc. · Apr 1998
SLT CL MD CONTACT LASER SYSTEM
K972548 · Surgical Laser Technologies, Inc. · Apr 1998
DENTEK LD 15 LASERSYSTEM
K974057 · Dentek Lasersystems Produktions Ges.M.B.H. · Apr 1998