Cleared Traditional

K983950 - CERALAS DIODE LASER SYSTEM (MODEL H)

K983950 is the FDA 510(k) clearance for CERALAS DIODE LASER SYSTEM (MODEL H) by Ceram Optec, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K983950 · Ceram Optec, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
90d
Days
Class 2
Risk

K983950 is an FDA 510(k) clearance for the CERALAS DIODE LASER SYSTEM (MODEL H). 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 Ceram Optec, Inc. (Washington, US). The FDA issued a Cleared decision on February 3, 1999 after a review of 90 days - within the typical 510(k) review window.

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 Ceram Optec, Inc. devices

Submission Details

510(k) Number K983950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1998
Decision Date February 03, 1999
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 1351
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K983950.
MODIFIED VERSAPULSE SELECT SINGLE WAVELENGTH, HO: YAG AND DUAL WAVELENGTH, HO: YAG/ND: YAG SURGICAL LASERS AND DELIVERY
K990947 · Lumenis, Inc. · Apr 1999
AURA DYE LASER SYSTEM (ADLS)
K984424 · Laserscope · Mar 1999
CANDELA GENTLELASE II DERMATOLOGICAL LASER
K984601 · Candela Corp. · Feb 1999
OPMI TWINER SURGICAL MICROSCOPE
K983868 · Carl Zeiss, Inc. · Jan 1999
CYNOSURE ERASURE LASER
K984517 · Cynosure, Inc. · Jan 1999
LASERSCOPE COOLSPOT
K984110 · Laserscope · Dec 1998