Cleared Traditional

K920865 - SHARPLAN 2100

K920865 is the FDA 510(k) clearance for SHARPLAN 2100 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 524-day FDA review.

K920865 · Sharplan Lasers, Inc. · General & Plastic Surgery device
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Aug 1993
Decision
524d
Days
Class 2
Risk

K920865 is an FDA 510(k) clearance for the SHARPLAN 2100,3000,SHARPLASER 65, 40. 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 August 2, 1993 after a review of 524 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Sharplan Lasers, Inc. devices

Submission Details

510(k) Number K920865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1992
Decision Date August 02, 1993
Days to Decision 524 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
409d slower than avg
Panel avg: 115d · This submission: 524d
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 K920865.
VISIDISC KITS, SPINESCOPE
K924720 · Laserscope · Oct 1993
SHARPLASE SHORT FIBER ND:YAG DELIVERY SYSTEM
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K924588 · Carl Zeiss, Inc. · Jul 1993
AP01 AND AP02
K925908 · Surgical Laser Technologies, Inc. · Jul 1993
MODEL 110 ND:YAG LASER
K931051 · Excel Tech. , Ltd. · Jun 1993