The Alma Opus System, Colibri Applicator and Tips— 510(k) K201520
Substantially EquivalentAlma Lasers, Inc.
FDA 510(k) clearance K201520 for The Alma Opus System, Colibri Applicator and Tips, Substantially Equivalent on 2021-10-27. Applicant: Alma Lasers, Inc.. Device class: 2.
Clearance details
- Applicant
- Alma Lasers, Inc.
- Product code
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Buffalo Grove, IL, US
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More clearances from Alma Lasers, Inc.
view allAdverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.