DIODENT DENTAL LASER SYSTEM— 510(k) K013216
Substantially EquivalentContinuum Electro-Optics, Inc.
FDA 510(k) clearance K013216 for DIODENT DENTAL LASER SYSTEM, Substantially Equivalent on 2002-02-27. Applicant: Continuum Electro-Optics, Inc.. Device class: 2.
Clearance details
- Applicant
- Continuum Electro-Optics, 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
- Santa Clara, CA, US
Recent devices under product code GEX
view allMore clearances from Continuum Electro-Optics, Inc.
view all- K022709 — MEDLITE Q-SWITHCED LASER
- K022351 — DIODENT DENTAL LASER SYSTEM
- K021616 — DELIGHT DENTAL ER: YAG LASER SYSTEM
- K014234 — MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER
- K011677 — MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG LASER
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.