Cleared Traditional

K971250 - LASERSCOPE MICROBEAM IV MICROMANIPULATOR

K971250 is an FDA 510(k) clearance for LASERSCOPE MICROBEAM IV MICROMANIPULATOR, manufactured by Laserscope. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K971250 · Laserscope · General & Plastic Surgery device
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Jun 1997
Decision
90d
Days
Class 2
Risk

K971250 is an FDA 510(k) clearance for the LASERSCOPE MICROBEAM IV MICROMANIPULATOR. 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 Laserscope (San Jose, US). The FDA issued a Cleared decision on June 30, 1997 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 Laserscope devices

FDA 510(k) Submission Details - K971250

510(k) Number K971250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1997
Decision Date June 30, 1997
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.

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 2239
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K971250.
CELL ROBOTICS ER: YAG SURGICAL LASER
K970461 · Cell Robotics, Inc. · Jul 1997
SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940/ERBIUM CRYSTALASE (FORMERLY TRILASE 2940 ERBIUM LASER
K971404 · Schwartz Electro-Optics, Inc. · Jul 1997
EPILIGHT HAIR REMOVAL SYSTEM
K963249 · Esc Medical Systems , Ltd. · Jul 1997
LASEAWAY LONG PULSE AND Q-SWITCHED RUBY LASER SYSTEM
K971193 · Polytec Pi, Inc. · Jun 1997
ORION SERIES SURGICAL LASER SYSTEM (Q-SWITCHED ND:YAG CONFIGURATION)
K964818 · Laserscope · Jun 1997
SOFTSCAN
K971024 · Sahar Technologies, Inc. · Jun 1997