UPGRADED PACKAGE FOR DLASE 300 PULSED DENTAL LASER— 510(k) K931774
Substantially EquivalentSunrise Technologies, Inc.
FDA 510(k) clearance K931774 for UPGRADED PACKAGE FOR DLASE 300 PULSED DENTAL LASER, Substantially Equivalent on 1993-07-22. Applicant: Sunrise Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Sunrise Technologies, 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
- Fremont, CA, US
Recent devices under product code GEX
view allMore clearances from Sunrise Technologies, 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.