Cleared Traditional

K983215 - MULTIPULSE CO2 LASER

K983215 is an FDA 510(k) clearance for MULTIPULSE CO2 LASER, manufactured by Aesculap-Meditec GmbH. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K983215 · Aesculap-Meditec GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
81d
Days
Class 2
Risk

K983215 is an FDA 510(k) clearance for the MULTIPULSE CO2 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 Aesculap-Meditec GmbH (Irvine, US). The FDA issued a Cleared decision on December 4, 1998 after a review of 81 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 Aesculap-Meditec GmbH devices

FDA 510(k) Submission Details - K983215

510(k) Number K983215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1998
Decision Date December 04, 1998
Days to Decision 81 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
34d faster than avg
Panel avg: 115d · This submission: 81d
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 1884
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K983215.
ACCU-PULSE 1000 CO2 SURGICAL LASER SYSTEM
K983543 · Argus Photonics Group · Dec 1998
SURECAUT DIAMOND LASER KNIFE
K983463 · Clinicon Corp. · Dec 1998
CELL ROBOTICS' LASETTE
K981746 · Cell Robotics, Inc. · Dec 1998
COMPACT KTP LASER
K983020 · Cosmos Medical Technology · Nov 1998
DORNIER MEDILA H
K983963 · Dornier Medtech America, Inc. · Nov 1998
AURORA
K981379 · Premier Laser Systems, Inc. · Nov 1998