Cleared Traditional

K861179 - CANDELA MODEL SPT-1

K861179 is the FDA 510(k) clearance for CANDELA MODEL SPT-1 by Candela Corp.. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K861179 · Candela Corp. · General & Plastic Surgery device
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Nov 1986
Decision
234d
Days
Class 2
Risk

K861179 is an FDA 510(k) clearance for the CANDELA MODEL SPT-1, PULSED DYE 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. (Natick, US). The FDA issued a Cleared decision on November 20, 1986 after a review of 234 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 K861179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1986
Decision Date November 20, 1986
Days to Decision 234 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 115d · This submission: 234d
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 K861179.
MODEL LS 840, CO2 LASER
K864563 · Cooper Lasersonics, Inc. · Apr 1987
OMNIPLUS FREQ DOUBLE ND:YAG PHOTOSURG SYS/NEURO
K862514 · Laserscope · Feb 1987
SAPPHIRE LASER BLADES (LASER BLADES) ND: YAG
K863086 · Cooper Lasersonics, Inc. · Dec 1986
ND:YAG LASER, MODEL 6000 FOR NEUROSURGERY
K863183 · Cooper Lasersonics, Inc. · Oct 1986
MODEL LS-870 CO2 SURGICAL LASER SYSTEM (MODIFIED)
K860831 · Cooper Lasersonics, Inc. · Oct 1986
MODEL 8900 ND:YAG LASER
K863433 · Cooper Lasersonics, Inc. · Sep 1986