Cleared Traditional

K921320 - ELIOS DIODE OPHTHALMIC LASER

K921320 is an FDA 510(k) clearance for ELIOS DIODE OPHTHALMIC LASER, manufactured by Marco Ophthalmic, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K921320 · Marco Ophthalmic, Inc. · General & Plastic Surgery device
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Jul 1992
Decision
105d
Days
Class 2
Risk

K921320 is an FDA 510(k) clearance for the ELIOS DIODE OPHTHALMIC LASER. 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 Marco Ophthalmic, Inc. (Jacksonville, US). The FDA issued a Cleared decision on July 2, 1992 after a review of 105 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Marco Ophthalmic, Inc. devices

FDA 510(k) Submission Details - K921320

510(k) Number K921320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1992
Decision Date July 02, 1992
Days to Decision 105 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
10d faster than avg
Panel avg: 115d · This submission: 105d
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 2348
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K921320.
ZEISS MULTI YAG LASER
K920967 · Carl Zeiss, Inc. · Jul 1992
CYNOSURE PHOTGENICA V CUTANEOUS VAS. LESION LASER
K921842 · Cynosure, Inc. · Jul 1992
EXCEL DUOPULSE MODEL 3000 COMBINATION HO/ER:YAG
K922375 · Excel Tech. , Ltd. · Jul 1992
LASERSCOPE'S DISPOSABLE LAPAROSTAT W/ FIBER DIVER
K921380 · Laserscope · Jun 1992
EXCEL DUOPAULSE MODEL 2000
K915679 · Excel Tech. , Ltd. · Jun 1992
ULTRALINE STERILE DISPOSABLE FIBER
K921807 · Heraeus Lasersonics, Inc. · Jun 1992