The Time Machine Series Lasers— 510(k) K152461
Substantially EquivalentMedical Lasers Manufacturer, Inc.
FDA 510(k) clearance K152461 for The Time Machine Series Lasers, Substantially Equivalent on 2016-07-08. Applicant: Medical Lasers Manufacturer, Inc..
Clearance details
- Applicant
- Medical Lasers Manufacturer, Inc.
- Product code
- Code ILY
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Freehold, NJ, US
Adverse events under product code ILY
product code ILY- Death
- 3
- Total
- 3
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.