Cleared Traditional

K883091 - SHARPLAN 4300 & 4310 ULTRASONIC SURGICA...

K883091 · Sharplan Lasers, Inc. · General & Plastic Surgery device

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Oct 1988

Decision

84d

Days

Risk

K883091 is an FDA 510(k) clearance for the SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Sharplan Lasers, Inc. (Allendale, US). The FDA issued a Cleared decision on October 14, 1988 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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	K883091 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 22, 1988
Decision Date	October 14, 1988
Days to Decision	84 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

31d faster than avg

Panel avg: 115d · This submission: 84d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	LFL Instrument, Ultrasonic Surgical
Device Class	-

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 88

Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K883091.

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CUSA(R) SYSTEM 200C/200T/200M/200H ULTRA ASPIRATOR

K910696 · Valleylab, Inc. · Jun 1991

CUSA SYSTEM 200C,T,M,H ULTRASONIC ASPIRATOR

K894600 · Valleylab, Inc. · Jan 1990

CUSA SYSTEM 200 MACRO-DISSECTOR

K864983 · Cooper Lasersonics, Inc. · Jun 1987

R PAK

K851203 · CooperVision, Inc. · Jul 1985

SUSZOI ULTRASONIC SURGICAL ASPIRATOR SONOP

K852539 · Johnson & Johnson Professionals, Inc. · Jul 1985

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K883091

Sharplan Lasers, Inc.

Allendale, NJ · US

STEPHEN DALTON

Regulatory profile

78 submissions 78 cleared

100% clearance rate · Active in General & Plastic Surgery

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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