ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6— 510(k) K051922
Substantially EquivalentCynosure, Inc.
FDA 510(k) clearance K051922 for ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6, Substantially Equivalent on 2005-09-14. Applicant: Cynosure, Inc.. Device class: 2.
Clearance details
- Applicant
- Cynosure, Inc.
- Product code
- Code ILY
- Device class
- Class 2
- Regulation
- 21 CFR 890.5500
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chelmsford, MA, US
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More clearances from Cynosure, Inc.
view allAdverse 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.