Cleared Traditional

K852252 - 870 SURGICAL SYS CONTROL PULSE MODIFICATION

K852252 is an FDA 510(k) clearance for 870 SURGICAL SYS CONTROL PULSE MODIFICATION, manufactured by Cooper Lasersonics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K852252 · Cooper Lasersonics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1985
Decision
33d
Days
Class 2
Risk

K852252 is an FDA 510(k) clearance for the 870 SURGICAL SYS CONTROL PULSE MODIFICATION. 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 Cooper Lasersonics, Inc. (Santa Clara, US). The FDA issued a Cleared decision on June 27, 1985 after a review of 33 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 Cooper Lasersonics, Inc. devices

FDA 510(k) Submission Details - K852252

510(k) Number K852252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1985
Decision Date June 27, 1985
Days to Decision 33 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 115d · This submission: 33d
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 1458
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K852252.
MINI-HALO(HAND-HELD) CO2 LASER SYSTEM
K853319 · Directed Energy, Inc. · Sep 1985
MODEL 451 CO2 SURGICAL LASER
K852190 · Coherent Medical Group · Aug 1985
COOPER LASERSONICS 880 CO2/ND:YAG MEDICAL LASER SY
K851000 · Cooper Lasersonics, Inc. · Aug 1985
LASERSCOPE OMNIPLUS PHOTOSURGICAL SYS ND:YAG
K850018 · Laserscope · Jun 1985
MINI-HALO CO2 LASER SYSTEM
K843915 · CooperVision, Inc. · May 1985
S.L.T. LASER DELIVERY HANDLES W/SURGICAL RODS
K844643 · Surgical Laser Technologies, Inc. · May 1985