Biolitec Medical Devices, Inc.
Grandville, MA, US
Biolitec Medical Devices, Inc. appears in FDA device records in Grandville, MA. FDA records list 9 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 9
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 9 510(k) clearances for Biolitec Medical Devices, Inc. between 2011 and 2012. The busiest year on record is 2012, with 5. The most recent is 2012, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 4 |
| 2012 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K120231 | EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL) | GEX | Substantially Equivalent | |
| K113688 | MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM | GEX | Substantially Equivalent | |
| K113858 | MEGABEAM ENDO-ENT PROBE | GEX | Substantially Equivalent | |
| K113709 | MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE | GEX | Substantially Equivalent | |
| K113792 | MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBE | GEX | Substantially Equivalent | |
| K112987 | TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM | GEX | Substantially Equivalent | |
| K112299 | ENDOVASCULAR LASER VEIN SYSTEM KIT | GEX | Substantially Equivalent | |
| K112442 | RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM | GEX | Substantially Equivalent | |
| K112324 | CERALAS 980NM DIODE LASER FAMILY | GEX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain