Cleared Traditional

K914423 - OPTIFIBER

K914423 is an FDA 510(k) clearance for OPTIFIBER, manufactured by Minimal Invasive Therapy and Diagnostics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K914423 · Minimal Invasive Therapy and Diagnostics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1991
Decision
60d
Days
Class 2
Risk

K914423 is an FDA 510(k) clearance for the OPTIFIBER. 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 Minimal Invasive Therapy and Diagnostics, Inc. (Washington, US). The FDA issued a Cleared decision on December 2, 1991 after a review of 60 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 Minimal Invasive Therapy and Diagnostics, Inc. devices

FDA 510(k) Submission Details - K914423

510(k) Number K914423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1991
Decision Date December 02, 1991
Days to Decision 60 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 115d · This submission: 60d
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 2478
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K914423.
LASER FIBEROPTIC DELIVERY SYSTEM
K915352 · Sunrise Technologies, Inc. · Dec 1991
C02 LASER WAVEGUIDE
K913887 · Heraeus Lasersonics, Inc. · Dec 1991
SHARPLAN SHARPLASE FAMILY OF HANDSWITCHED ND:YAG
K914089 · Sharplan Lasers, Inc. · Dec 1991
KTP/532 AND KTP/YAG
K913758 · Laserscope · Nov 1991
MODEL DLASE 500 ND:YAG LASE SYS:INTRA SFT TIS SURG
K914677 · Sunrise Technologies, Inc. · Nov 1991
POLARIS, OPHTHALMOLOGY
K911926 · Pfizer Laser Systems · Nov 1991