NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810— 510(k) K101152

Name: FDA 510(k) clearance K101152
Creator: U.S. Food and Drug Administration
Published: 2010-08-18

Substantially Equivalent

Focus Medical, LLC

FDA 510(k) clearance K101152 for NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810, Substantially Equivalent on 2010-08-18. Applicant: Focus Medical, LLC. Device class: 2.

Clearance details

Applicant: Focus Medical, LLC
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2010-04-23
Decision date: 2010-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethel, CT, US

Download summary PDF View on FDA.gov ↗

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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.