Cleared Traditional

K921841 - CYNOSURE PHOTOGENICA P PIGMENTED LESION...

K921841 is the FDA 510(k) clearance for CYNOSURE PHOTOGENICA P PIGMENTED LESION... by Cynosure, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K921841 · Cynosure, Inc. · General & Plastic Surgery device
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Aug 1992
Decision
109d
Days
Class 2
Risk

K921841 is an FDA 510(k) clearance for the CYNOSURE PHOTOGENICA P PIGMENTED 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 August 4, 1992 after a review of 109 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 K921841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1992
Decision Date August 04, 1992
Days to Decision 109 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
6d faster than avg
Panel avg: 115d · This submission: 109d
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 K921841.
CYNOSURE PHOTOGENICA T TATTOO REMOVAL LASER
K923683 · Cynosure, Inc. · Oct 1992
KTP/532 & KTP/YAG
K913990 · Laserscope · Sep 1992
CYNOSURE PHOTODENT, INTRAORAL SURGICAL LASER
K921843 · Cynosure, Inc. · Aug 1992
LASERSCOPE'S MICROSPOT DERMASTAT
K914918 · Laserscope · Jul 1992
CYNOSURE PHOTOTRIPTER LASER
K921840 · Cynosure, Inc. · Jul 1992
SLT LASER DELIVERY SYSTEM
K922634 · Surgical Laser Technologies, Inc. · Jul 1992