510(k) K113852
- Device
- BAUSCH & LOMB IOL INJECTOR
- Applicant
- BAUSCH & LOMB, INC.
- 510(k) number
- K113852
- Product code
- MSS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-09-28
- Date received
- 2011-12-29
- Regulation
- 886.4300
- Classification name
- Folders And Injectors, Intraocular Lens (iol)
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JASON SMITH
- Address
- 30 Enterprise Suite 450 Alusi Vuejo CA US 92656 92656
FDA Registration Numbers#
- 9710098
- 3017636737
- 9613160
- 2024311
- 9681862
- 2024024
- 3024715547
- 2648035
- 3008449456
- 1119421
- 1000635309
- 2023826
- 3009646326
- 2529709
- 3007125265
- 3006946276
- 3012236936
- 3003365815
- 1610287
- 1313525
- 1038833
- 3014173684
- 1037089
- 1119279
- 3015177648
- 3008132398
- 3007207818
- 9614546
- 2030624
- 1047843
- 3008344633
- 2242450
- 3007127244
- 2011171
- 3006234591
- 2523835
- 1063199
- 1932180
- 3012712027
- 3006723646
- 3007530141
- 3010126268
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 |
| K192005 | Bausch + Lomb PreVue Inserter for enVista Preloaded | Bausch & Lomb, Inc. | 2019-10-04 |
| 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 |
Legacy Summary#
summary
FDA Review#
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