Cleared Traditional

K994437 - CYNOSURE PHOTOGENICA SPIR

K994437 is an FDA 510(k) clearance for CYNOSURE PHOTOGENICA SPIR, 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 19-day FDA review.

K994437 · Cynosure, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
19d
Days
Class 2
Risk

K994437 is an FDA 510(k) clearance for the CYNOSURE PHOTOGENICA SPIR. 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 January 18, 2000 after a review of 19 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 - K994437

510(k) Number K994437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1999
Decision Date January 18, 2000
Days to Decision 19 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
96d faster than avg
Panel avg: 115d · This submission: 19d
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 K994437.
MODEL 1000 HOLMIUM LASER SYSTEM
K994273 · New Star Lasers, Inc. · Jan 2000
LITESABER 2000
K993942 · Laser Dental Innovations · Jan 2000
CYNOSURE M2 DERMATOLOGY LASER FOR HAIR REMOVAL
K994427 · Cynosure, Inc. · Jan 2000
DELIGHT II HAIR REMOVAL SYSTEM (THE DELIGHT SYSTEM)
K992482 · Radiancy, Ltd. · Dec 1999
SOFTLIGHT Q-SWITCHED ND: YAG LASER WITH OPTIONAL BEAM-SHRINKING HANDPIECE ACCESSORY
K993209 · Thermolase Corp. · Dec 1999
INTRALASE 600C LASER KERATOME
K993153 · Intra Lase Corp. · Dec 1999