DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER— 510(k) K992013
Substantially EquivalentContinuum Biomedical, Inc.
FDA 510(k) clearance K992013 for DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER, Substantially Equivalent on 1999-09-08. Applicant: Continuum Biomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Continuum Biomedical, 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
- Dublin, CA, US
Recent devices under product code GEX
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view all- K983054 — MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND: YAG LASER
- K973719 — MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YAG LASER
- K970808 — MEDLITE IV Q-SWITCHED, FREQUENCY DOUBLED, ND:YAG LASER
- K971903 — SCANNING DEVICE ACCESSORY FOR USE WITH THE CB DIODE/532 ND:YAG LASER
- K971879 — SCANNING DEVICE ACCESSORY FOR USE WITH THE CB ERBIUM/2.94 ER: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.