biolase.comWaterlase IPLus
Biolase, Inc.
BIOLASE, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2027755 | 2027755 | BIOLASE, INC. | 1 | N | 2020-04-25 | 4 CROMWELL Irvine CA US 92618 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00647529001042 | Waterlase Laser Tips - A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems. | 1-800-321-6717 | Waterlaseservice@biolase.com |
| 00647529003442 | Waterlase Laser Tips - A reusable fiberoptic tip accessory intended for use with Waterlase laser delivery systems. | 1-800-321-6717 | Waterlaseservice@biolase.com |
| 00647529003602 | Waterlase Laser Tips - A reusable fiberoptic tip accessory intended for use with Waterlase All-Tissue Laser Systems. The tip is made of sapphire and is packaged individually in plastic cases. | 1-800-321-6717 | Waterlaseservice@biolase.com |
| 00647529003732 | Waterlase Laser Tips - A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems. | 1-800-321-6717 | Waterlaseservice@biolase.com |
| 00647529004074 | EdgePro - A reusable fiberoptic tip accessory intended for use with EdgePro Laser System (Juno). | 1-800-321-6717 | Waterlaseservice@biolase.com |
| 00647529004081 | EdgePro - A reusable fiberoptic tip accessory intended for use with EdgePro Laser System (Juno). | 1-800-321-6717 | Waterlaseservice@biolase.com |
| 00647529004722 | Waterlase iPlus Dental Laser System - An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories (protective eyewear, power cords, tip cleaning kit). The patient-contacting components of the delivery system require sterilization prior to use. | 1-800-321-6717 | Waterlaseservice@biolase.com |
| 00647529004777 | Waterlase iPlus Dental Laser System - An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories (protective eyewear, power cords, tip cleaning kit). The patient-contacting components of the delivery system require sterilization prior to use. | 1-800-321-6717 | Waterlaseservice@biolase.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 79180 | 1518440958 | K192430 | Epic 980 | GEX | 2019-12-04 |
| 79180 | 1403005809 | K172771 | Epic Pro 940 | GEX | 2017-11-29 |
| 79180 | 1020706877 | K163128 | Epic Pro | GEX | 2017-01-11 |
| 79180 | 1870622965 | K161669 | Waterlase Express | GEX | 2016-07-28 |
| 79180 | 1729549630 | K130465 | EPIC 10S | GEX | 2013-04-11 |
| 79180 | 1389476202 | K121286 | EPIC 10 | GEX | 2012-09-28 |
| 79180 | 1403911116 | K101658 | WATERLASE MD TURBO PLUS MODEL 7200XXX | GEX | 2010-08-11 |
| 79180 | 1786961999 | K093852 | EZLASE 3 LASER SYSTEM | GEX | 2010-03-12 |
| 79180 | 1083047480 | K090181 | WATERLASE MD | GEX | 2009-02-11 |
| 79180 | 1647900206 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GEX | 9 | 2019-12-04 |
PMN#
Epic 980
Biolase, Inc.
Waterlase Laser System Family
Biolase, Inc.
Waterlase Express
Biolase, Inc.
WATERLASE IPLUS S
BIOLASE, INC.
EPIC 10
BIOLASE, INC.
GUDID#
Waterlase iPlus Dental Laser System - An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories (protective eyewear, power cords, tip cleaning kit). The patient-contacting components of the delivery system require sterilization prior to use.
2025-01-31
Waterlase iPlus Dental Laser System - An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories (protective eyewear, power cords, tip cleaning kit). The patient-contacting components of the delivery system require sterilization prior to use.
2025-01-31
Waterlase Laser Tips - A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
2016-09-16
Waterlase Laser Tips - A reusable fiberoptic tip accessory intended for use with Waterlase laser delivery systems.
2017-04-17
Waterlase Laser Tips - A reusable fiberoptic tip accessory intended for use with Waterlase All-Tissue Laser Systems. The tip is made of sapphire and is packaged individually in plastic cases.
2017-10-01
Waterlase Laser Tips - A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
2023-08-01
EdgePro - A reusable fiberoptic tip accessory intended for use with EdgePro Laser System (Juno).
2023-06-19
EdgePro - A reusable fiberoptic tip accessory intended for use with EdgePro Laser System (Juno).
2023-06-19
EdgePro - A reusable fiberoptic tip accessory intended for use with EdgePro Laser System (Juno).
2023-06-19
EdgePro - A reusable fiberoptic tip accessory intended for use with EdgePro Laser System (Juno).
2023-06-19
EdgePro - A reusable fiberoptic tip accessory intended for use with EdgePro Laser System (Juno).
2023-06-19
Waterlase Laser Tips - A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
2023-06-12
Waterlase iPlus Dental Laser System - A kit including a handpiece and tips intended to be utilized with an all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories (protective eyewear, power cords, tip cleaning kit). The patient-contacting components of the delivery system require sterilization prior to use.
2023-08-01
EdgePro - A reusable fiberoptic tip accessory intended for use with EdgePro Laser System (Juno).
2023-06-19
Waterlase Laser Tips - A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
2023-06-12
Waterlase Express - A kit composed of single-use fiberoptic accessories intended for use with the Waterlase Express all-tissue dental laser system in soft-tissue and hard-tissue procedures.
2023-06-12
Waterlase Laser Tips - A reusable fiberoptic accessory intended for use with Waterlase laser delivery systems.
2016-09-16
Waterlase Laser Tips - A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
2016-09-16
Waterlase Laser Tips - A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
2016-09-16
Waterlase Laser Tips - A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
2016-09-16
Waterlase Laser Tips - A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
2016-09-16
Waterlase Laser Tips - A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
2016-09-16
Waterlase Laser Tips - A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
2016-09-16
Waterlase Laser Tips - A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
2016-09-16
Waterlase Laser Tips - A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
2016-09-16
Waterlase Laser Tips - A single-use laser tip intended for use with Waterlase Laser Systems.
2016-09-16
Waterlase Laser Tips - A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
2016-09-16
Waterlase Laser Tips - A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
2016-09-16
Waterlase Laser Tips - A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
2016-09-16
Waterlase Laser Tips - A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
2016-09-16
Waterlase Laser Tips - A reusable fiberoptic accessory intended for use with Waterlase laser delivery systems.
2016-09-16
Waterlase Laser Tips - A reusable fiberoptic accessory intended for use with Waterlase laser delivery systems.
2016-09-16
Waterlase Laser Tips - A reusable fiberoptic accessory intended for use with Waterlase laser delivery systems.
2016-09-16
Waterlase Laser Tips - A reusable fiberoptic accessory intended for use with Waterlase laser delivery systems.
2016-09-16
Waterlase Laser Tips - A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
2016-09-16
Waterlase Laser Tips - A reusable fiberoptic accessory intended for use with Waterlase laser delivery systems.
2016-09-16
Waterlase Laser Tips - A single-use fiberoptic accessory intended for use with Waterlase Laser delivery systems.
2016-09-16
Waterlase Laser Tips - A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
2016-09-16
Waterlase Laser Tips - A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
2016-09-16
Waterlase Laser Tips - A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
2016-09-16