15W CERALAS D 1470NM DIODE LASER, MODEL D1470— 510(k) K082225
Substantially EquivalentBiolitec, Inc.
FDA 510(k) clearance K082225 for 15W CERALAS D 1470NM DIODE LASER, MODEL D1470, Substantially Equivalent on 2008-12-03. Applicant: Biolitec, Inc.. Device class: 2.
Clearance details
- Applicant
- Biolitec, 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
- Special
- Location
- Washington, DC, US
Recent devices under product code GEX
view allMore clearances from Biolitec, Inc.
view all- K112013 — EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER
- K112253 — CERALAS 147NM DIODE LASER SYSTEM
- K110080 — RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
- K102755 — CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS HPD MULTIWAVELENGHT 980NM/ 1470NM FIBER-COUPLED DIODE LASER
- K101712 — ENDOVASCULAR LAER VEIN SYSTEM KIT
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.