RxSight® Insertion Device (63002)
FDA 510(k) K231838 · Rxsight, Inc.
510(k) numberK231838
Submission
- Device name
- RxSight® Insertion Device (63002)
- Applicant
- Rxsight, Inc.
Aliso Viejo, CA, US - Received
- June 22, 2023
- Decision date
- August 15, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSS – Folders And Injectors, Intraocular Lens (Iol)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4300
- Specialty
- Ophthalmic
Other 510(k)s with product code MSS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261174 | RxSight® Insertion DeviceMSS · Special | Rxsight, Inc. | 06/10/2026SE |
| K252540 | ACCUJECT Injector Set 2.1-1P (LP604590)MSS · Traditional | Medicel AG | 09/16/2025SE |
| K242389 | EyeGility Inserter for Preloaded enVista IOLsMSS · Traditional | Bausch & Lomb, Incorporated | 10/10/2024SE |
| K231106 | Accuject Refra Injector AR2900MSS · Traditional | Medicel AG | 09/19/2023SE |
| K231466 | RxSight Insertion DeviceMSS · Special | Rxsight, Inc. | 06/12/2023SE |
| K212039 | CLAREON MONARCH IV IOL Delivery SystemMSS · Traditional | Alcon Laboratories, Inc. | 08/23/2021SE |
| K200057 | bioli lOL Delivery SystemMSS · Traditional | Ast Products, Inc. | 06/04/2020SE |
| K192926 | RxSight Insertion DeviceMSS · Traditional | Rxsight, Inc. | 01/17/2020SE |
| K192005 | Bausch + Lomb PreVue Inserter for enVista PreloadedMSS · Special | Bausch & Lomb, Inc. | 10/04/2019SE |
| K191949 | UNFOLDER Vitan InserterMSS · Abbreviated | Johnson & Johnson Surgical Vision, Inc. | 09/13/2019SE |
More from Johnson & Johnson Surgical Vision, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261174 | RxSight® Insertion DeviceMSS · Special | 06/10/2026SE |
| K231466 | RxSight Insertion DeviceMSS · Special | 06/12/2023SE |
| K201909 | RxSight Contact LensHJK · Traditional | 09/10/2020SE |
| K192926 | RxSight Insertion DeviceMSS · Traditional | 01/17/2020SE |
| K181401 | RxSight Insertion DeviceMSS · Traditional | 07/26/2018SE |
Questions and answers
When was RxSight® Insertion Device (63002) cleared by the FDA?
RxSight® Insertion Device (63002) (K231838) received a 510(k) decision of Substantially Equivalent on August 15, 2023, 54 days after the submission was received.
What is the product code of K231838?
The FDA product code is MSS – Folders And Injectors, Intraocular Lens (Iol), a Class I (low risk) device regulated under 21 CFR 886.4300.