Bioli LOL Delivery System
AST Products, Inc.
AST Products, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1000635309 | 1000635309 | AST Products, Inc. | 1 | N | 2026-01-01 | 9 LINNELL CIR Billerica MA US 01821 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 177788 | 1104547536 | K200057 | bioli lOL Delivery System | MSS | 2020-06-04 |
| 177788 | 1704809983 | K182965 | BL-Cart IOL Delivery Cartridge | MSS | 2019-03-29 |
| 177788 | 1845294313 | K172228 | pioli IOL Delivery System | MSS | 2017-12-15 |
| 177788 | 1681097296 | K142056 | LIOLI IOL DELIVERY SYSTEM | MSS | 2015-04-09 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MSS | 4 | 2020-06-04 |
PMN#
BL-Cart IOL Delivery Cartridge
AST Products, Inc.
Pioli IOL Delivery System
AST Products, Inc.
LIOLI IOL DELIVERY SYSTEM
AST PRODUCTS, INC.
GUDID#
pioli™ IOL Delivery System - Single-use, Sterile Intraocular Lens Injector Only for the Insertion of IOL Models Validated for Use with this Device as Indicated in the IOL Approved Labeling
2026-04-01
lioli™ IOL Delivery System - Single-use, Sterile Intraocular Lens Injector Only for the Insertion of IOL Models Validated for Use with this Device as Indicated in the IOL Approved Labeling
2018-09-14
lioli™ IOL Delivery System - Single-use, Sterile Intraocular Lens Injector Only for the Insertion of IOL Models Validated for Use with this Device as Indicated in the IOL Approved Labeling
2018-09-14
lioli™ IOL Delivery System - Single-use, Sterile Intraocular Lens Injector Only for the Insertion of IOL Models Validated for Use with this Device as Indicated in the IOL Approved Labeling
2018-09-14
pioli™ IOL Delivery System - Single-use, Sterile Intraocular Lens Injector Only for the Insertion of IOL Models Validated for Use with this Device as Indicated in the IOL Approved Labeling
2018-09-14
bioli™ IOL Delivery System - The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through an incision.The bioli™ IOL Delivery System is only for the insertion of Lenstec Softec I IOL and IOL models validated for use with this device as indicated in the approved IOL labeling.
2020-12-07
bioli™ IOL Delivery System - The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through an incision.The bioli™ IOL Delivery System is only for the insertion of Lenstec Softec I IOL and IOL models validated for use with this device as indicated in the approved IOL labeling.
2020-12-07
bioli™ IOL Delivery System - The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through an incision.The bioli™ IOL Delivery System is only for the insertion of Lenstec Softec I IOL and IOL models validated for use with this device as indicated in the approved IOL labeling.
2020-12-07
bioli™ IOL Delivery System - The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through an incision.The bioli™ IOL Delivery System is only for the insertion of Lenstec Softec I IOL and IOL models validated for use with this device as indicated in the approved IOL labeling.
2022-10-03
bioli™ IOL Delivery System - The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through an incision. The bioli™ IOL Delivery System is only for the insertion of Lenstec Softec I IOL and IOL models validated for use with this device as indicated in the approved IOL labeling.
2022-10-03
bioli™ IOL Delivery System - The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through an incision. The bioli™ IOL Delivery System is only for the insertion of Lenstec Softec I IOL and IOL models validated for use with this device as indicated in the approved IOL labeling.
2020-12-07
bioli™ IOL Delivery System - The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through an incision. The bioli™ IOL Delivery System is only for the insertion of Lenstec Softec I IOL and IOL models validated for use with this device as indicated in the approved IOL labeling.
2020-12-07
bioli™ IOL Delivery System - The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through an incision. The bioli™ IOL Delivery System is only for the insertion of Lenstec Softec I IOL and IOL models validated for use with this device as indicated in the approved IOL labeling.
2020-12-07
BL-Cart™ IOL Delivery Cartridge - The BL-Cart™ IOL Delivery Cartridge is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through a surgical procedure. The cartridge is intended to be used in conjunction with Alcon Monarch® III IOL Delivery System injector.The BL-Cart™ IOL Delivery Cartridge is only for the insertion of Lenstec Softec I IOL and IOL models validated for use with this device as indicated in the approved IOL labeling.
2019-10-04