Cleared Traditional

K934811 - PLTL-1 & PLDL-1 510NM PULSED DYE LASERS

K934811 is the FDA 510(k) clearance for PLTL-1 & PLDL-1 510NM PULSED DYE LASERS by Candela Laser Corp.. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K934811 · Candela Laser Corp. · General & Plastic Surgery device
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Sep 1994
Decision
329d
Days
Class 2
Risk

K934811 is an FDA 510(k) clearance for the PLTL-1 & PLDL-1 510NM PULSED DYE LASERS. 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 Laser Corp. (Wayland, US). The FDA issued a Cleared decision on September 1, 1994 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Laser Corp. devices

Submission Details

510(k) Number K934811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1993
Decision Date September 01, 1994
Days to Decision 329 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
214d slower than avg
Panel avg: 115d · This submission: 329d
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 1170
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K934811.
CANDELA H:ERB LASER
K921995 · Candela Laser Corp. · Nov 1994
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K944090 · Candela Laser Corp. · Sep 1994
KARL STORZ LASER ACCESSORIES
K942786 · KARL STORZ Endoscopy-America, Inc. · Sep 1994
SLT PRISM/REFRACTING PROBE
K934208 · Surgical Laser Technologies, Inc. · Aug 1994
SHARPLAN MODEL 1080S CO2 SURGICAL LASER
K933918 · Sharplan Lasers, Inc. · Aug 1994
SMARTSCAN
K941841 · Laserscope · Aug 1994