Cleared Traditional

K944625 - MODEL 210-AC ASPIRATING ENDOPHOTOCOAGUL...

K944625 is an FDA 510(k) clearance for MODEL 210-AC ASPIRATING ENDOPHOTOCOAGUL..., manufactured by Mnlase, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K944625 · Mnlase, Inc. · General & Plastic Surgery device
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Nov 1994
Decision
44d
Days
Class 2
Risk

K944625 is an FDA 510(k) clearance for the MODEL 210-AC ASPIRATING ENDOPHOTOCOAGULATOR 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 Mnlase, Inc. (Reston, US). The FDA issued a Cleared decision on November 3, 1994 after a review of 44 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 Mnlase, Inc. devices

FDA 510(k) Submission Details - K944625

510(k) Number K944625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1994
Decision Date November 03, 1994
Days to Decision 44 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
71d faster than avg
Panel avg: 115d · This submission: 44d
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 1564
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K944625.
CANDELA H:ERB LASER
K921995 · Candela Laser Corp. · Nov 1994
CURVED ENDOPHOTOCOAGULATOR LASER PROBE
K944470 · Mnlase, Inc. · Nov 1994
STRAIGHT ENDOPHOTOCOAGULATOR LASER PROBE
K944471 · Mnlase, Inc. · Nov 1994
MODEL 210-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER
K944626 · Mnlase, Inc. · Nov 1994
MODEL 220-SC CURVED ENDOPHOTOCOAGULATOR LASER
K944627 · Mnlase, Inc. · Nov 1994
MODEL 220-SS LASER DELIVERY PROBE
K944628 · Mnlase, Inc. · Nov 1994