MODEL DLASER 1000 ND; YAG LASER SYSTEM— 510(k) K914568

Name: FDA 510(k) clearance K914568
Creator: U.S. Food and Drug Administration
Published: 1991-11-07

Substantially Equivalent

Sunrise Technologies, Inc.

FDA 510(k) clearance K914568 for MODEL DLASER 1000 ND; YAG LASER SYSTEM, Substantially Equivalent on 1991-11-07. Applicant: Sunrise Technologies, Inc.. Device class: 2.

Clearance details

Device name as filed: MODEL DLASER 1000 ND;YAG LASER SYSTEM
Applicant: Sunrise Technologies, Inc.
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 1991-10-15
Decision date: 1991-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GEX

view all

K261562 — Diode Laser Therapy System2026-09-10
K262426 — Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)2026-09-10
K261589 — 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)2026-09-02
K262269 — CO2 Laser System (MBT- CO2 Laser)2026-09-01
K261821 — 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)2026-08-27

More clearances from Sunrise Technologies, Inc.

view all

K962192 — SUNRISE CURING LAMP1996-09-03
K942542 — SLASE 210 PLUS HOLMIUM LASER SYSTEM1994-09-01
K932997 — MICROPREP CAVITY PREPERATION SYSTEM1994-04-25
K933007 — SLASE 210 & SLASE 210 PLUS HOLMIUM LASER SYSTEMS1994-01-10
K933017 — MODEL 5030 SUCTION HANDPIECE SYSTEM1993-07-26

Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.