Cleared Traditional

K923599 - OPTILITE FIBEROPTIC DELIVERY SYSTEMS

K923599 is an FDA 510(k) clearance for OPTILITE FIBEROPTIC DELIVERY SYSTEMS, manufactured by Xintec Corporation. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K923599 · Xintec Corporation · General & Plastic Surgery device
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May 1993
Decision
301d
Days
Class 2
Risk

K923599 is an FDA 510(k) clearance for the OPTILITE FIBEROPTIC DELIVERY SYSTEMS. 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 Xintec Corporation (Oakland, US). The FDA issued a Cleared decision on May 17, 1993 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Xintec Corporation devices

FDA 510(k) Submission Details - K923599

510(k) Number K923599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1992
Decision Date May 17, 1993
Days to Decision 301 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
186d slower than avg
Panel avg: 115d · This submission: 301d
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 1533
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K923599.
ZEISS LASER INDIRECT OPHTHALMOSCOPE
K924588 · Carl Zeiss, Inc. · Jul 1993
AP01 AND AP02
K925908 · Surgical Laser Technologies, Inc. · Jul 1993
MODEL 110 ND:YAG LASER
K931051 · Excel Tech. , Ltd. · Jun 1993
CONBIO-MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM
K922935 · Buckman Co., Inc. · Apr 1993
OPTICON(TM) CONNECTOR ADAPTER
K930159 · Xintec Corporation · Apr 1993
ZEISS VISULAS DIODE LASER
K923274 · Carl Zeiss, Inc. · Apr 1993