Cleared Traditional

K981746 - CELL ROBOTICS' LASETTE

K981746 is an FDA 510(k) clearance for CELL ROBOTICS' LASETTE, manufactured by Cell Robotics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K981746 · Cell Robotics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
203d
Days
Class 2
Risk

K981746 is an FDA 510(k) clearance for the CELL ROBOTICS' LASETTE. 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 Cell Robotics, Inc. (Albuquerque, US). The FDA issued a Cleared decision on December 7, 1998 after a review of 203 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 Cell Robotics, Inc. devices

FDA 510(k) Submission Details - K981746

510(k) Number K981746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1998
Decision Date December 07, 1998
Days to Decision 203 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
88d slower than avg
Panel avg: 115d · This submission: 203d
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 K981746.
LASEAWAY ALEXANDRITE LASER SYSTEM
K982316 · Silver Creek, Inc. · Dec 1998
ACCU-PULSE 1000 CO2 SURGICAL LASER SYSTEM
K983543 · Argus Photonics Group · Dec 1998
SURECAUT DIAMOND LASER KNIFE
K983463 · Clinicon Corp. · Dec 1998
MULTIPULSE CO2 LASER
K983215 · Aesculap-Meditec GmbH · Dec 1998
COMPACT KTP LASER
K983020 · Cosmos Medical Technology · Nov 1998
DORNIER MEDILA H
K983963 · Dornier Medtech America, Inc. · Nov 1998