Cleared Traditional

K980398 - KAPLAN PENDULASER 115 SURGICAL LASER WITH OPTOSCAN II

K980398 is an FDA 510(k) clearance for KAPLAN PENDULASER 115 SURGICAL LASER WI..., manufactured by Optomedic Medical Technologies , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K980398 · Optomedic Medical Technologies , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
232d
Days
Class 2
Risk

K980398 is an FDA 510(k) clearance for the KAPLAN PENDULASER 115 SURGICAL LASER WITH OPTOSCAN II. 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 Optomedic Medical Technologies , Ltd. (Rockville, US). The FDA issued a Cleared decision on September 22, 1998 after a review of 232 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 Optomedic Medical Technologies , Ltd. devices

FDA 510(k) Submission Details - K980398

510(k) Number K980398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1998
Decision Date September 22, 1998
Days to Decision 232 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
117d slower than avg
Panel avg: 115d · This submission: 232d
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 1883
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K980398.
CENTAURI
K983211 · Premier Laser Systems, Inc. · Oct 1998
UMECO OPTIMA 694 RUBY LASER SYSTEM
K982113 · Umeco, Inc. · Sep 1998
LASETTE LASER SKIN PERFORATOR
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DILKES LASER/SUCTION CANNULAE
K981143 · Exmoor Plastics , Ltd. · Sep 1998
DORNIER MEDILAS D
K982629 · Dornier Surgical Products, Inc. · Sep 1998
DERMA K ER:YAG/CO2 LASER
K982827 · Esc Medical Systems, Inc. · Sep 1998