Cleared Traditional

K974381 - CANDELA GENTLELASE GL DERMATOLOGICAL LASER

K974381 is an FDA 510(k) clearance for CANDELA GENTLELASE GL DERMATOLOGICAL LASER, manufactured by Candela Corp.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K974381 · Candela Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
82d
Days
Class 2
Risk

K974381 is an FDA 510(k) clearance for the CANDELA GENTLELASE GL 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 Candela Corp. (Wayland, US). The FDA issued a Cleared decision on February 10, 1998 after a review of 82 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 Candela Corp. devices

FDA 510(k) Submission Details - K974381

510(k) Number K974381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1997
Decision Date February 10, 1998
Days to Decision 82 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
33d faster than avg
Panel avg: 115d · This submission: 82d
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 K974381.
ALEX TA2 ERASER
K980131 · Light Age, Inc. · Feb 1998
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K973867 · Schwartz Electro-Optics, Inc. · Feb 1998
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K974229 · Laser Peripherals, LLC · Feb 1998
RESPOSABLE BARE FIBERS
K973172 · Trimedyne, Inc. · Feb 1998
HM-RUBY
K974142 · American Lasers, Inc. · Jan 1998
STARLIGHT PULSED DIODE ARRAY LASER SYSTEM
K974346 · Star Medical Technologies, Inc. · Jan 1998