Cleared Traditional

K981627 - PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE)

K981627 is an FDA 510(k) clearance for PROTEGE II ER: YAG LASER SYSTEM AND ACC..., manufactured by Xintec Corporation. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K981627 · Xintec Corporation · General & Plastic Surgery device
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Jul 1998
Decision
85d
Days
Class 2
Risk

K981627 is an FDA 510(k) clearance for the PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE). 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 Xintec Corporation (Oakland, US). The FDA issued a Cleared decision on July 31, 1998 after a review of 85 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 Xintec Corporation devices

FDA 510(k) Submission Details - K981627

510(k) Number K981627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1998
Decision Date July 31, 1998
Days to Decision 85 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEX Device Classification - Class 2, Special Controls

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 2193
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K981627.
COMBINATION ND:YAG AND FREQUENCY DOUBLED SOLID STATE GREEN LASER
K981952 · Instruments For Medicine and Diagnostics · Sep 1998
PEGASUS ND:YAG LASER SYSTEM
K980559 · Premier Laser Systems, Inc. · Aug 1998
NIDEK LIGHTSCAN
K982295 · Nidek, Inc. · Aug 1998
MEGABEAM REUSABLE FIBER OPTIC HANDPIECE AND NEEDLES
K980389 · Ceram Optec, Inc. · Jul 1998
EPILASER NORMAL MODE RUBY LASER
K980517 · Palomar Medical Products, Inc. · Jul 1998
DORNIER MEDILAS E
K981438 · Dornier Surgical Products, Inc. · Jul 1998