Cleared Traditional

K884182 - SURGILASE YAG 100 SURGIPROBES & SURGISC...

K884182 is the FDA 510(k) clearance for SURGILASE YAG 100 SURGIPROBES & SURGISC... by Surgilase, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K884182 · Surgilase, Inc. · General & Plastic Surgery device
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Jan 1989
Decision
118d
Days
Class 2
Risk

K884182 is an FDA 510(k) clearance for the SURGILASE YAG 100 SURGIPROBES & SURGISCALPEL. 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 Surgilase, Inc. (Warwick, US). The FDA issued a Cleared decision on January 24, 1989 after a review of 118 days - within the typical 510(k) review window.

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 Surgilase, Inc. devices

Submission Details

510(k) Number K884182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1988
Decision Date January 24, 1989
Days to Decision 118 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 115d · This submission: 118d
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 737
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K884182.
SHARPLAN MODEL 2106
K891016 · Sharplan Lasers, Inc. · Mar 1989
MODIFIED LABELING & PACKAGING OF SHARPLAN 2100
K890040 · Sharplan Lasers, Inc. · Feb 1989
SHARPLAN COMBINED CO2/ND:YAG LASER MICRO. #749
K890059 · Sharplan Lasers, Inc. · Feb 1989
SHARPLAN-MEDILAS 4060N YAG LASER & SERIES 2900 TIP
K884994 · Sharplan Lasers, Inc. · Dec 1988
SHARPLAN 2100 ND:YAG LASER, SERIES 2900 SYN. TIPS
K883563 · Sharplan Lasers, Inc. · Sep 1988
FULLER IRFLEX FIBER OPTIC SURGICAL LASER SYSTEM
K880061 · Abbott Laboratories · Jun 1988