Cleared Traditional

K022923 - CANDELA GENTLE YAG LASER SYSTEM

K022923 is the FDA 510(k) clearance for CANDELA GENTLE YAG LASER SYSTEM by Candela Corp.. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K022923 · Candela Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
190d
Days
Class 2
Risk

K022923 is an FDA 510(k) clearance for the CANDELA GENTLE YAG LASER 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 Candela Corp. (Wayland, US). The FDA issued a Cleared decision on March 13, 2003 after a review of 190 days - an extended review 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: 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 Candela Corp. devices

Submission Details

510(k) Number K022923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2002
Decision Date March 13, 2003
Days to Decision 190 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
75d slower than avg
Panel avg: 115d · This submission: 190d
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 K022923.
SMARTXIDE
K031224 · Cynosure, Inc. · May 2003
CANDELA GENTLE LASE FAMILY OF LASER SYSTEM
K024371 · Candela Corp. · Mar 2003
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
K024260 · Candela Corp. · Mar 2003
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
K024335 · Candela Corp. · Mar 2003
CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG
K022951 · Candela Corp. · Jan 2003
SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921
K023624 · Surgical Laser Technologies, Inc. · Jan 2003