Cleared Traditional

K900345 - SHARPLAN ND:YAG LASERS FOR ENT AND NECK...

K900345 is the FDA 510(k) clearance for SHARPLAN ND:YAG LASERS FOR ENT AND NECK... 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 77-day FDA review.

K900345 · Sharplan Lasers, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1990
Decision
77d
Days
Class 2
Risk

K900345 is an FDA 510(k) clearance for the SHARPLAN ND:YAG LASERS FOR ENT AND NECK SURGERY. 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 April 10, 1990 after a review of 77 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 K900345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1990
Decision Date April 10, 1990
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
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 1419
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K900345.
MODELS 4000/4900/6000/8000/8900, LUXAS&1700 ND:YAG
K900630 · Heraeus Lasersonics, Inc. · May 1990
HERAEUS LASERSONICS CO2 WAVEGUIDE DELIVERY SYSTEM
K900751 · Heraeus Lasersonics, Inc. · May 1990
LASER LAPAROSCOPIC CHOLECYSTECTOMY
K901541 · Surgical Laser Technologies, Inc. · Apr 1990
KTP/532 SURGICAL LASER SYSTEM W/KTP/YAG MODULE
K895945 · Laserscope · Apr 1990
MODEL 20-CH CARBON DIOXIDE LASER W/ADD'L USES
K900253 · Pfizer Laser Systems · Apr 1990
SHARPLAN ND:YAG LASER LAPAROSCOPIC CHOLECYSTECTOMY
K900346 · Sharplan Lasers, Inc. · Apr 1990