Cleared Traditional

K900153 - SHARPLAN ND:YAG DISPOSABLE FIBER DELIVE...

K900153 is the FDA 510(k) clearance for SHARPLAN ND:YAG DISPOSABLE FIBER DELIVE... by Sharplan Lasers, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K900153 · Sharplan Lasers, Inc. · General & Plastic Surgery device
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Mar 1990
Decision
67d
Days
Class 2
Risk

K900153 is an FDA 510(k) clearance for the SHARPLAN ND:YAG DISPOSABLE FIBER DELIVERY SYSTEM. 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 Sharplan Lasers, Inc. (Washington, D.C., US). The FDA issued a Cleared decision on March 19, 1990 after a review of 67 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 Sharplan Lasers, Inc. devices

Submission Details

510(k) Number K900153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1990
Decision Date March 19, 1990
Days to Decision 67 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 115d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Boston Scientific
Donna M Gardner

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GEX Powered Laser Surgical Instrument

All 1420
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K900153.
SHARPLAN MODEL 1055 SEALED CO2 SURGICAL LASER
K900592 · Sharplan Lasers, Inc. · Mar 1990
SHARPLAN FLEXIBLE CO2 SURGICAL LASER APPLICATOR
K900076 · Sharplan Lasers, Inc. · Mar 1990
NIDEK, INC. BIO-DC LASER DELIVERY SYSTEM
K900165 · Nidek, Inc. · Mar 1990
SHARPLAN 1041 SEALED-OFF CO2 SURGICAL LASER SYSTEM
K900077 · Sharplan Lasers, Inc. · Mar 1990
OPTILASE YAG MODEL 1000 ACV SURGICAL LASER SYSTEM
K897157 · Trimedyne, Inc. · Feb 1990
SHARPLAN ND:YAG LASER FOR ARTHROSCOPY/MENISCECTOMY
K896762 · Sharplan Lasers, Inc. · Feb 1990