Cleared Traditional

K921995 - CANDELA H:ERB LASER

K921995 is the FDA 510(k) clearance for CANDELA H:ERB LASER 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 923-day FDA review.

K921995 · Candela Laser Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
923d
Days
Class 2
Risk

K921995 is an FDA 510(k) clearance for the CANDELA H:ERB 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 Laser Corp. (Wayland, US). The FDA issued a Cleared decision on November 7, 1994 after a review of 923 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Candela Laser Corp. devices

Submission Details

510(k) Number K921995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1992
Decision Date November 07, 1994
Days to Decision 923 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
808d slower than avg
Panel avg: 115d · This submission: 923d
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 K921995.
CANDELA Q-SWITCHED ALEXANDRITE LASER
K940173 · Candela Laser Corp. · Dec 1994
LATERALASE, MODIFIED
K944204 · Trimedyne, Inc. · Nov 1994
COAXIAL ENDOSTAT
K944977 · Laserscope · Nov 1994
CANDELA ALEX LAZR Q-SWITCHED ALEXANDRITE LASER
K944090 · Candela Laser Corp. · Sep 1994
KARL STORZ LASER ACCESSORIES
K942786 · KARL STORZ Endoscopy-America, Inc. · Sep 1994
PLTL-1 & PLDL-1 510NM PULSED DYE LASERS
K934811 · Candela Laser Corp. · Sep 1994