CERALAS 980NM DIODE LASER FAMILY— 510(k) K112324
Substantially EquivalentBiolitec Medical Devices, Inc.
FDA 510(k) clearance K112324 for CERALAS 980NM DIODE LASER FAMILY, Substantially Equivalent on 2011-09-06. Applicant: Biolitec Medical Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- Biolitec Medical Devices, 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
- Grandville, MA, US
Recent devices under product code GEX
view allMore clearances from Biolitec Medical Devices, Inc.
view all- K120231 — EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL)
- K113688 — MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM
- K113858 — MEGABEAM ENDO-ENT PROBE
- K113709 — MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE
- K113792 — MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBE
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.