COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160— 510(k) K062210
Substantially EquivalentNew Star Lasers, Inc.
FDA 510(k) clearance K062210 for COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160, Substantially Equivalent on 2006-09-25. Applicant: New Star Lasers, Inc..
Clearance details
- Applicant
- New Star Lasers, Inc.
- Product code
- Code GEX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Roseville, CA, US
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, through . 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.