TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER— 510(k) K072995
Substantially EquivalentLumen Development and Manufacturing, Inc.
FDA 510(k) clearance K072995 for TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER, Substantially Equivalent on 2007-12-18. Applicant: Lumen Development and Manufacturing, Inc..
Clearance details
- Applicant
- Lumen Development and Manufacturing, Inc.
- Product code
- Code GEX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sandy, UT, US
Adverse 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.