Cleared Traditional

K914568 - MODEL DLASER 1000 ND

Also marketed or referenced as:
YAG LASER SYSTEM

K914568 is an FDA 510(k) clearance for MODEL DLASER 1000 ND, 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 23-day FDA review.

K914568 · Sunrise Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1991
Decision
23d
Days
Class 2
Risk

K914568 is an FDA 510(k) clearance for the MODEL DLASER 1000 ND. 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 November 7, 1991 after a review of 23 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 - K914568

510(k) Number K914568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1991
Decision Date November 07, 1991
Days to Decision 23 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
92d faster than avg
Panel avg: 115d · This submission: 23d
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 1749
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K914568.
KTP/532 AND KTP/YAG
K913758 · Laserscope · Nov 1991
MODEL DLASE 500 ND:YAG LASE SYS:INTRA SFT TIS SURG
K914677 · Sunrise Technologies, Inc. · Nov 1991
POLARIS, OPHTHALMOLOGY
K911926 · Pfizer Laser Systems · Nov 1991
CARBON DIOXIDE LASER SYSTEMS W/WAVEGUIDE DELIVERY
K910530 · Heraeus Lasersonics, Inc. · Oct 1991
NIDEK MODELS AC-2100 & 2200
K913465 · Nidek, Inc. · Oct 1991
COMPAC A, ELITE A, ELITE A PLUS, SURGICA A
K913569 · Hgm Medical Laser Systems, Inc. · Oct 1991