Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family— 510(k) K142924
Substantially EquivalentShaser, Inc.
FDA 510(k) clearance K142924 for Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family, Substantially Equivalent on 2015-02-13. Applicant: Shaser, Inc.. Device class: 2.
Clearance details
- Applicant
- Shaser, Inc.
- Product code
- Code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lexington, MA, US
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More clearances from Shaser, Inc.
view allAdverse 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.