Cleared Traditional

K884682 - LIVING TECHNOLOGY LASER CONTACT TIPS

K884682 is an FDA 510(k) clearance for LIVING TECHNOLOGY LASER CONTACT TIPS, manufactured by Living Technology, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K884682 · Living Technology, Inc. · General & Plastic Surgery device
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Jan 1989
Decision
58d
Days
Class 2
Risk

K884682 is an FDA 510(k) clearance for the LIVING TECHNOLOGY LASER CONTACT TIPS. 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 Living Technology, Inc. (Warminster, US). The FDA issued a Cleared decision on January 5, 1989 after a review of 58 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 Living Technology, Inc. devices

FDA 510(k) Submission Details - K884682

510(k) Number K884682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1988
Decision Date January 05, 1989
Days to Decision 58 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 115d · This submission: 58d
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 2497
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K884682.
MODELS 4000/4900/6000/8000/8900 ND:YAG & 1700 CO2
K883379 · Heraeus Lasersonics, Inc. · Jan 1989
SURGILASE YAG 100 SURGIPROBES & SURGISCALPEL
K884182 · Surgilase, Inc. · Jan 1989
(HLI) CARBON DIOXIDE SYSTEMS W/INFRAGUIDE CO2
K885181 · Heraeus Lasersonics, Inc. · Jan 1989
CO2 LASER SYSTEM & ARTHOGUIDE CO2 LASER FIBER DEL.
K883488 · Heraeus Lasersonics, Inc. · Dec 1988
LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE
K884459 · Luxar Corp. · Dec 1988
SHARPLAN-MEDILAS 4060N YAG LASER & SERIES 2900 TIP
K884994 · Sharplan Lasers, Inc. · Dec 1988