Cleared Traditional

K952006 - ACCU-BEAM FIBER OPTIC HANDPIECE

K952006 is the FDA 510(k) clearance for ACCU-BEAM FIBER OPTIC HANDPIECE by Tti Medical. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K952006 · Tti Medical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
33d
Days
Class 2
Risk

K952006 is an FDA 510(k) clearance for the ACCU-BEAM FIBER OPTIC HANDPIECE. 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 Tti Medical (Pleasanton, US). The FDA issued a Cleared decision on May 31, 1995 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 Tti Medical devices

Submission Details

510(k) Number K952006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1995
Decision Date May 31, 1995
Days to Decision 33 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
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.

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 1201
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K952006.
MODIFIED COHERENT ULTRAPULSE CO2 SURGICAL LASERS
K951812 · Lumenis, Inc. · Jul 1995
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K951165 · Sharplan Lasers, Inc. · Jun 1995
SHARPLAN MODEL 712 ACUSPOT MICROMANIPULATOR
K951204 · Sharplan Lasers, Inc. · Jun 1995
ALEXLAZR
K950831 · Candela Laser Corp. · May 1995
ADD POWER FAMILY , MICRO ADDSTAT
K945614 · Laserscope · May 1995
SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM FAMILY
K931490 · Surgical Laser Technologies, Inc. · May 1995