Cleared Traditional

K910530 - CARBON DIOXIDE LASER SYSTEMS W/WAVEGUID...

K910530 is the FDA 510(k) clearance for CARBON DIOXIDE LASER SYSTEMS W/WAVEGUID... by Heraeus Lasersonics, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K910530 · Heraeus Lasersonics, Inc. · General & Plastic Surgery device
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Oct 1991
Decision
265d
Days
Class 2
Risk

K910530 is an FDA 510(k) clearance for the CARBON DIOXIDE LASER SYSTEMS W/WAVEGUIDE DELIVERY. 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 Heraeus Lasersonics, Inc. (Milpitas, US). The FDA issued a Cleared decision on October 31, 1991 after a review of 265 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 Heraeus Lasersonics, Inc. devices

Submission Details

510(k) Number K910530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1991
Decision Date October 31, 1991
Days to Decision 265 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
150d slower than avg
Panel avg: 115d · This submission: 265d
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 K910530.
C02 LASER WAVEGUIDE
K913887 · Heraeus Lasersonics, Inc. · Dec 1991
SHARPLAN SHARPLASE FAMILY OF HANDSWITCHED ND:YAG
K914089 · Sharplan Lasers, Inc. · Dec 1991
KTP/532 AND KTP/YAG
K913758 · Laserscope · Nov 1991
NIDEK MODELS AC-2100 & 2200
K913465 · Nidek, Inc. · Oct 1991
DORNIER LASER LITHOTRIPTER IMPACT
K913191 · Dornier Medtech America, Inc. · Oct 1991
LATERALASE(TM) CATHETER WITH THERMAL FEEDBACK
K913109 · Trimedyne, Inc. · Oct 1991