CB ERBIUM/2.94(TM) ER:YAG LASER— 510(k) K970934
Substantially EquivalentContinuum Biomedical, Inc.
FDA 510(k) clearance K970934 for CB ERBIUM/2.94(TM) ER:YAG LASER, Substantially Equivalent on 1997-06-11. 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
view allMore clearances from Continuum Biomedical, Inc.
view all- K992013 — DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER
- 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
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.