510(k) K192005
- Device
- Bausch + Lomb PreVue Inserter For EnVista Preloaded
- Applicant
- Bausch & Lomb, Inc
- 510(k) number
- K192005
- Product code
- MSS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-10-04
- Date received
- 2019-07-29
- Regulation
- 886.4300
- Classification name
- Folders And Injectors, Intraocular Lens (iol)
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Rekha Janarthanan
- Address
- 3365 Tree Ct. Industrial Blvd. St. Louis MO US 63122 63122
FDA Registration Numbers#
- 3024715547
- 1932180
- 1610287
- 1037089
- 3017636737
- 1047843
- 2024024
- 1038833
- 2011171
- 3008449456
- 3006234591
- 2023826
- 3012236936
- 9614546
- 2523835
- 2648035
- 2024311
- 1119279
- 3008132398
- 3014173684
- 1063199
- 2242450
- 9710098
- 3010126268
- 3009646326
- 3007530141
- 9613160
- 3007207818
- 2529709
- 2030624
- 1000635309
- 3007127244
- 1313525
- 3015177648
- 1119421
- 3006723646
- 3008344633
- 3006946276
- 9681862
- 3012712027
- 3007125265
- 3003365815
Source Documents#
Other 510(k) Records For Product Code MSS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252540 | ACCUJECT Injector Set 2.1-1P (LP604590) | Medicel AG | 2025-09-16 |
| K242389 | EyeGility™ Inserter for Preloaded enVista IOLs | Bausch & Lomb, Incorporated | 2024-10-10 |
| K231106 | Accuject Refra Injector AR2900 | Medicel AG | 2023-09-19 |
| K231838 | RxSight® Insertion Device (63002) | Rxsight, Inc. | 2023-08-15 |
| K231466 | RxSight Insertion Device | Rxsight, Inc. | 2023-06-12 |
| K212039 | CLAREON MONARCH IV IOL Delivery System | Alcon Laboratories, Inc. | 2021-08-23 |
| K200057 | bioli lOL Delivery System | Ast Products, Inc. | 2020-06-04 |
| K192926 | RxSight Insertion Device | Rxsight, Inc. | 2020-01-17 |
| K191949 | UNFOLDER Vitan Inserter | Johnson & Johnson Surgical Vision, Inc. | 2019-09-13 |
| K182965 | BL-Cart IOL Delivery Cartridge | Ast Products, Inc. | 2019-03-29 |
| K181401 | RxSight Insertion Device | Rxsight, Inc. | 2018-07-26 |
| K172228 | pioli IOL Delivery System | Ast Products, Inc. | 2017-12-15 |
| K173480 | Crystalsert Lens Delivery System | Bausch & Lomb, Inc. | 2017-12-11 |
| K172375 | MicroSTAAR Injector System Cartridges | STAAR Surgical Company | 2017-09-06 |
| K161776 | Lenstec LC Injection system | Lenstec, Inc. | 2016-11-29 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases