Cleared Traditional

K930582 - SHARPLAN SHARPLASE LATERAL ND:YAG FIBER

K930582 is the FDA 510(k) clearance for SHARPLAN SHARPLASE LATERAL ND:YAG FIBER 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 271-day FDA review.

K930582 · Sharplan Lasers, Inc. · General & Plastic Surgery device
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Nov 1993
Decision
271d
Days
Class 2
Risk

K930582 is an FDA 510(k) clearance for the SHARPLAN SHARPLASE LATERAL ND:YAG FIBER. 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. (Allendale, US). The FDA issued a Cleared decision on November 2, 1993 after a review of 271 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 Sharplan Lasers, Inc. devices

Submission Details

510(k) Number K930582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1993
Decision Date November 02, 1993
Days to Decision 271 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
156d slower than avg
Panel avg: 115d · This submission: 271d
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 Peers - GEX Powered Laser Surgical Instrument

All 1417
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K930582.
BOSTON SCIENTIFIC CORPORATION SIDE FIRING LASER GUIDE
K933715 · Boston Scientific Corp · Nov 1993
ORION YAG LASER SYSTEM OPHTHALMOLOGY
K910826 · Pfizer Laser Systems · Nov 1993
ORION
K911288 · Pfizer Laser Systems · Nov 1993
ZEISS OPMILAS 144 SURGICAL LASERS
K933322 · Carl Zeiss, Inc. · Oct 1993
VISIDISC KITS, SPINESCOPE
K924720 · Laserscope · Oct 1993
SHARPLASE SHORT FIBER ND:YAG DELIVERY SYSTEM
K931978 · Sharplan Lasers, Inc. · Sep 1993