SLS CHROMOS 694 QD RUBY LASER TO BE RENAMED MEHL QD RUBY LASER SYSTEM FOR HAIR REMOVAL— 510(k) K962109

Name: FDA 510(k) clearance K962109
Creator: U.S. Food and Drug Administration
Published: 1997-03-13

Substantially Equivalent

Classy Lady by Mehl of Puerto Rico, Inc.

FDA 510(k) clearance K962109 for SLS CHROMOS 694 QD RUBY LASER TO BE RENAMED MEHL QD RUBY LASER SYSTEM FOR HAIR REMOVAL, Substantially Equivalent on 1997-03-13. Applicant: Classy Lady by Mehl of Puerto Rico, Inc.. Device class: 2.

Clearance details

Applicant: Classy Lady by Mehl of Puerto Rico, Inc.
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 1996-05-31
Decision date: 1997-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Budd Lake, NJ, 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.