BIOLASE MG LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2027755 | 2027755 | BIOLASE MG LLC | 1 | N | 2026-01-01 | 27042 Towne Centre Drive Suite 270 Foothill Ranch CA US 92610 |
| 3017125161 | 3017125161 | BIOLASE MG LLC | 1 | N | 2026-01-01 | 4225 Prado Road Suite 102 Corona CA US 92880 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 335662 | 1633898231 | K213428 | EdgePro | NVK | 2021-12-22 |
| 335724 | 1633898231 | K213428 | EdgePro | NVK | 2021-12-22 |
| 335724 | 1776142385 | K210183 | Waterlase iPLus | GEX | 2022-04-21 |
| 335662 | 1776142385 | K210183 | Waterlase iPLus | GEX | 2022-04-21 |
| 335662 | 1343822897 | K192430 | Epic 980 | GEX | 2019-12-04 |
| 335724 | 1343822897 | K192430 | Epic 980 | GEX | 2019-12-04 |
| 335724 | 2067314539 | K172771 | Epic Pro 940 | GEX | 2017-11-29 |
| 335662 | 2067314539 | K172771 | Epic Pro 940 | GEX | 2017-11-29 |
| 335662 | 1214287592 | K163128 | Epic Pro | GEX | 2017-01-11 |
| 335724 | 1214287592 | K163128 | Epic Pro | GEX | 2017-01-11 |
| 335662 | 1568277975 | K161669 | Waterlase Express | GEX | 2016-07-28 |
| 335724 | 1568277975 | K161669 | Waterlase Express | GEX | 2016-07-28 |
| 335662 | 1271135530 | K130465 | EPIC 10S | GEX | 2013-04-11 |
| 335724 | 1271135530 | K130465 | EPIC 10S | GEX | 2013-04-11 |
| 335662 | 1343740127 | K121286 | EPIC 10 | GEX | 2012-09-28 |
| 335724 | 1343740127 | K121286 | EPIC 10 | GEX | 2012-09-28 |
| 335724 | 1075494269 | K101658 | WATERLASE MD TURBO PLUS MODEL 7200XXX | GEX | 2010-08-11 |
| 335662 | 1075494269 | K101658 | WATERLASE MD TURBO PLUS MODEL 7200XXX | GEX | 2010-08-11 |
| 335724 | 1437286504 | K093852 | EZLASE 3 LASER SYSTEM | GEX | 2010-03-12 |
| 335662 | 1437286504 | K093852 | EZLASE 3 LASER SYSTEM | GEX | 2010-03-12 |
| 335662 | 1752381985 | K090181 | WATERLASE MD | GEX | 2009-02-11 |
| 335724 | 1752381985 | K090181 | WATERLASE MD | GEX | 2009-02-11 |
| 335662 | 1238772526 | K031140 | WATERLASE | GEX | 2004-07-07 |
| 335724 | 1238772526 | K031140 | WATERLASE | GEX | 2004-07-07 |