Cleared Traditional

K914827 - LPI ML210 HOLMIUM SURGICAL LASER, MODIFICATION

K914827 is an FDA 510(k) clearance for LPI ML210 HOLMIUM SURGICAL LASER, manufactured by Laser Photonics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K914827 · Laser Photonics, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Mar 1992
Decision
157d
Days
Class 2
Risk

K914827 is an FDA 510(k) clearance for the LPI ML210 HOLMIUM SURGICAL LASER, MODIFICATION. 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 Laser Photonics, Inc. (Orlando, US). The FDA issued a Cleared decision on March 27, 1992 after a review of 157 days - an extended review 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: 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 Laser Photonics, Inc. devices

FDA 510(k) Submission Details - K914827

510(k) Number K914827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1991
Decision Date March 27, 1992
Days to Decision 157 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
42d slower than avg
Panel avg: 115d · This submission: 157d
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 2460
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K914827.
ZEISS MULTIYAG LASER
K920529 · Carl Zeiss, Inc. · Apr 1992
LATERALASE
K920625 · Trimedyne, Inc. · Apr 1992
SIDE FIRING FIBERS
K920632 · Trimedyne, Inc. · Apr 1992
CO2 LASER AND WAVEGUIDE DELIVERY SYSTEMS FOR THOR.
K915583 · Heraeus Lasersonics, Inc. · Mar 1992
ZEISS MULTIYAG LASER
K915840 · Carl Zeiss, Inc. · Mar 1992
OPTICA 25 ND:YAG DENTAL LASER SYSTEM
K913839 · Xintec Corporation · Mar 1992