Cleared Traditional

K920107 - ADL 800 ND:YAG LASER SYSTEM FOR INTRAORAL TIS. SUR

K920107 is an FDA 510(k) clearance for ADL 800 ND:YAG LASER SYSTEM FOR INTRAOR..., manufactured by Sunrise Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K920107 · Sunrise Technologies, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Mar 1992
Decision
64d
Days
Class 2
Risk

K920107 is an FDA 510(k) clearance for the ADL 800 ND:YAG LASER SYSTEM FOR INTRAORAL TIS. SUR. 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 Sunrise Technologies, Inc. (Fremont, US). The FDA issued a Cleared decision on March 13, 1992 after a review of 64 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 Sunrise Technologies, Inc. devices

FDA 510(k) Submission Details - K920107

510(k) Number K920107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1992
Decision Date March 13, 1992
Days to Decision 64 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
51d faster than avg
Panel avg: 115d · This submission: 64d
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 1748
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K920107.
ZEISS MULTIYAG LASER
K915840 · Carl Zeiss, Inc. · Mar 1992
OPTICA 25 ND:YAG DENTAL LASER SYSTEM
K913839 · Xintec Corporation · Mar 1992
ADL 400 ND
K920106 · Sunrise Technologies, Inc. · Mar 1992
SHARPLAN MODELS 100 SERIES C02 LASERS/ACCESSORIES
K914455 · Sharplan Lasers, Inc. · Mar 1992
ZEISS MULTIYAG LASER
K915561 · Carl Zeiss, Inc. · Mar 1992
CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM
K915497 · Continuum Biomedical, Inc. · Mar 1992