ADL 400 ND; YAG LASER SYSTEM FOR INTRORAL SOFT TIS.— 510(k) K920106

Name: FDA 510(k) clearance K920106
Creator: U.S. Food and Drug Administration
Published: 1992-03-13

Substantially Equivalent

Sunrise Technologies, Inc.

FDA 510(k) clearance K920106 for ADL 400 ND; YAG LASER SYSTEM FOR INTRORAL SOFT TIS., Substantially Equivalent on 1992-03-13. Applicant: Sunrise Technologies, Inc.. Device class: 2.

Clearance details

Device name as filed: ADL 400 ND;YAG LASER SYSTEM FOR INTRORAL SOFT TIS.
Applicant: Sunrise Technologies, Inc.
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 1992-01-09
Decision date: 1992-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

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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.