RxSight® Insertion Device

K261174 · Rxsight, Inc. · MSS · Jun 10, 2026 · Ophthalmic

Device Facts

• Record ID: K261174
• Device Name: RxSight® Insertion Device
• Applicant: Rxsight, Inc.
• Product Code: MSS · Ophthalmic
• Decision Date: Jun 10, 2026
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.4300
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

The RxSight Insertion Device is indicated for the folding and insertion of a 3-piece silicone, intraocular lens into the human eye through a surgical incision. The RxSight Insertion Device is intended for the insertion of the RxSight Light Adjustable Lens®, RxSight Light Adjustable Lens+(TM), and IOL models validated for use with this device in IOL approved labeling.

Device Story

RxSight Insertion Devices (Models 63000/63001 and 63002) facilitate folding and insertion of 3-piece silicone IOLs during cataract surgery. Model 63000/63001 consists of a reusable titanium handpiece and single-use polypropylene cartridge; Model 63002 is a sterile, single-use device (polycarbonate/polybutylene terephthalate injector with polypropylene cartridge). Operation involves placing the IOL into a loading cartridge, snapping the cartridge into the handpiece, and using a screw plunger to advance and fold the lens through the cartridge into the eye. Used by surgeons in clinical settings. Output is the physical delivery of the IOL into the eye. Benefits include consistent, controlled lens delivery through small incisions, minimizing surgical trauma.

Clinical Evidence

Bench testing only. Simulated surgical manipulation and recovery of properties performed per ISO 11979-3:2012; optical properties and homogeneity verified per ISO 11979-2:2014. Biocompatibility testing conducted per ISO 10993-1, -5, -10, -11, -12, and -23. All testing met acceptance criteria equivalent to predicate devices.

Technological Characteristics

Models 63000/63001: Reusable titanium handpiece, single-use polypropylene cartridge. Model 63002: Single-use polycarbonate/polybutylene terephthalate injector, single-use polypropylene cartridge. Both use screw-plunger mechanical actuation. Cartridges feature LubriMATRIX™ coating. Sterilization: Autoclave (handpiece), Ethylene Oxide (cartridges, SAL 10^-6). Compliant with ISO 11979-2/3 and ISO 10993 standards.

Indications for Use

Indicated for folding and insertion of 3-piece silicone intraocular lenses (IOLs) into the human eye through a surgical incision in adult patients (22 years and older).

Regulatory Classification

Identification

An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.

Predicate Devices

• RxSight Insertion Device (K231466)
• RxSight Insertion Device (K231838)

Submission Summary (Full Text)

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**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION

June 10, 2026

% Maureen O'Connell
Executive Vice President, Clinical and Regulatory Affairs
RxSight, Inc.
100 Columbia, Aliso Viejo, CA 92656 USA

Re: K261174

Trade/Device Name: RxSight Insertion Devices (Model 63000/63001 and Model 63002)

Regulation Number: 21 CFR 886.4300

Regulation Name: Intraocular Lens Guide

Regulatory Class: Class I, reserved

Product Code: MSS

Dated: May 19, 2026

Received: May 19, 2026

Dear Maureen O'Connell:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K261174 - Maureen O'Connell

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K261174 - Maureen O'connell

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Bennett Walker, Ph.D.
Assistant Director
DHT1A: Division of Ophthalmic Devices
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Bennett Walker, Ph.D.

Assistant Director

DHT1A: Division of Ophthalmic Devices

OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT, and Dental Devices

Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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# Indications for Use

| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | | K261174 | ? |
| --- | --- | --- | --- |
| Please provide the device trade name(s). | | | ? |
| RxSight® Insertion Device | | | |
| Please provide your Indications for Use below. | | | ? |
| The RxSight Insertion Device is indicated for the folding and insertion of a 3-piece silicone, intraocular lens into the human eye through a surgical incision. The RxSight Insertion Device is intended for the insertion of the RxSight Light Adjustable Lens®, RxSight Light Adjustable Lens+(TM), and IOL models validated for use with this device in IOL approved labeling. | | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | | ? |

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510(K) SUMMARY

# 510(K) SUMMARY
K261174

This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92(a).

**APPLICANT:** RxSight, Inc.
100 Columbia
Aliso Viejo, CA 92656

**CONTACT PERSON:** Maureen O'Connell
Executive Vice President, Clinical and Regulatory Affairs
[e-mail]
Tel: [phone]

**DATE SUMMARY PREPARED:** June 8, 2026

**TRADE NAME:** RxSight Insertion Device

**COMMON NAME:** Intraocular Lens (IOL) Injector

**CLASSIFICATION NAME:** Folders and Injectors, Intraocular Lens (IOL)

**DEVICE CLASSIFICATION:** Class I; 21 CFR 886.4300

**PRODUCT CODE:** MSS

**PREDICATE DEVICE:** RxSight Insertion Device cleared in K231466 and K231838

# Device Description

The RxSight Insertion Device (Model 63000/63001) is a two-part intraocular lens (IOL) injector device comprised of a re-usable handheld titanium Injector Handpiece, and a single use, non-preloaded disposable polypropylene Injector Cartridge intended to be used together to fold and insert the intraocular lenses into the eye through a small incision during cataract surgery.

The RxSight Insertion Device (Model 63002) is a sterile, single-use device used to fold and insert intraocular lenses (IOL) into the eye through a small incision during cataract surgery. The RxSight Insertion Device (Model 63002) consists of:

- A single-use, disposable, sterile IOL inserter with a non-pyrogenic cartridge
- A single-use, disposable, sterile haptic puller.

510(k) Premarket Notification
RxSight, Inc.

Insertion Devices (Model 63000/63001 and 63002)

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510(K) SUMMARY

### Indications for Use

The RxSight Insertion Device is indicated for the folding and insertion of a 3-piece silicone, intraocular lens into the human eye through a surgical incision. The RxSight Insertion Device is intended for the insertion of the RxSight Light Adjustable Lens®, RxSight Light Adjustable Lens+™, and IOL models validated for use with this device in IOL approved labeling.

### Technological Characteristics Comparison

A comparison of the technological characteristics of the proposed and predicate devices is provided in the tables below.

#### Comparison of the RxSight Insertion Device (Model 63000/63001) to the Predicate Device

| | RxSight Insertion Device (Model 63000/63001) Subject Device | RxSight Insertion Device (Model 63000/63001) Predicate Device (K231466) |
| --- | --- | --- |
| **Product Code** | MSS | MSS |
| **Indications for Use** | The RxSight® Insertion Device is indicated for the folding and insertion of a 3-piece silicone, intraocular lens into the human eye through a surgical incision. The RxSight Insertion Device is intended for the insertion of the RxSight Light Adjustable Lens®, RxSight Light Adjustable Lens+™, and IOL models validated for use with this device in IOL approved labeling. | The RxSight® Insertion Device is indicated for the folding and insertion of a 3-piece silicone, intraocular lens into the human eye through a surgical incision. The RxSight Insertion Device is intended for the insertion of the RxSight Light Adjustable Lens®, RxSight Light Adjustable Lens+™, the Bausch & Lomb L161A0 IOL and IOL models validated for use with this device in IOL approved labeling. |
| **Operating Principle** | An intraocular lens (IOL) is placed in a loading cartridge. Cartridge snapped into the handpiece. Screw plunger advances the IOL through the cartridge which folds the IOL and advances it into the eye. | An intraocular lens (IOL) is placed in a loading cartridge. Cartridge snapped into the handpiece. Screw plunger advances the IOL through the cartridge which folds the IOL and advances it into the eye. |
| **Pre-loaded IOL** | No | No |
| **Material (Injector)** | Titanium | Titanium |
| **Material (cartridge)** | Polypropylene (resin mixture) | Polypropylene |

510(k) Premarket Notification
RxSight, Inc.

Insertion Devices (Model 63000/63001 and 63002)

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510(K) SUMMARY

| | RxSight Insertion Device (Model 63000/63001) Subject Device | RxSight Insertion Device (Model 63000/63001) Predicate Device (K231466) |
| --- | --- | --- |
| **Cartridge Coating** | LubriMATRIX™ | LubriMATRIX™ |
| **How Supplied (Reusable/Single Use)** | Handpiece - Reusable Cartridge - Single Use, supplied sterile | Handpiece - Reusable Cartridge - Single Use, supplied sterile |
| **Method of Sterilization** | Handpiece - Autoclave Cartridge - Ethylene Oxide to SAL 10^{-6} | Handpiece - Autoclave Cartridge - Ethylene Oxide to SAL 10^{-6} |
| **Shelf-life (Cartridge)** | 18-month | 12-month |

# **Comparison of the RxSight Insertion Device (Model 63002) to the Predicate Device**

| | RxSight Insertion Device (Model 63002) Subject Device | RxSight Insertion Device (Model 63002) Predicate Device (K231838) |
| --- | --- | --- |
| **Product Code** | MSS | MSS |
| **Indications for Use** | The RxSight® Insertion Device is indicated for the folding and insertion of a 3-piece silicone, intraocular lens into the human eye through a surgical incision. The RxSight Insertion Device is intended for the insertion of the RxSight Light Adjustable Lens®, RxSight Light Adjustable Lens+, and IOL models validated for use with this device in IOL approved labeling. | The RxSight® Insertion Device (Model 63002) is indicated for the folding and insertion of a 3-piece silicone, intraocular lens into the human eye through a surgical incision. The RxSight Insertion Device (Model 63002) is intended for the insertion of the RxSight Light Adjustable Lens®, RxSight Light Adjustable Lens+, and IOL models validated for use with this device in IOL approved labeling. |
| **Operating Principle** | An intraocular lens (IOL) is placed in a loading cartridge. Screw plunger advances the IOL through the cartridge which folds the IOL and advances it into the eye. | An intraocular lens (IOL) is placed in a loading cartridge. Screw plunger advances the IOL through the cartridge which folds the IOL and advances it into the eye. |

510(k) Premarket Notification
RxSight, Inc.

Insertion Devices (Model 63000/63001 and 63002)

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510(K) SUMMARY

| | RxSight Insertion Device (Model 63002) Subject Device | RxSight Insertion Device (Model 63002) Predicate Device (K231838) |
| --- | --- | --- |
| **Pre-loaded IOL** | No | No |
| **Material (Injector)** | Polycarbonate Polybutylene terephthalate polymer | Polycarbonate Polybutylene terephthalate polymer |
| **Material (Cartridge)** | Polypropylene (resin mixture) | Polypropylene |
| **Cartridge Coating** | LubriMATRIX™ | LubriMATRIX™ |
| **How Supplied (Reusable/Single Use)** | Sterile and Single use | Sterile and Single use |
| **Method of Sterilization** | Ethylene Oxide to SAL 10^{-6} | Ethylene Oxide to SAL 10^{-6} |
| **Shelf-life** | 18-month | 18-month |

#### Summary of Performance Test Results

The descriptive characteristics are well-defined and adequate to ensure equivalence of the RxSight Insertion Devices (Model 63000/63001 and Model 63002) with the predicate devices. The subject devices and their predicates met the same requirements of non-clinical performance testing (simulated surgical manipulation and recovery of properties) including both pre- and post-injection evaluation of the intraocular lenses (IOLs) in accordance with ISO 11979-3:2012. Specifically, dimensions and sagitta were verified following lens delivery and compared to the measurements performed prior to the lens delivery per ISO 11979-3:2012. Additionally, recovery of optical properties and overall surface and bulk homogeneity were tested and met the requirements pre and post lens injection per ISO 11979-2:2014. Biocompatibility testing was performed per relevant parts of ISO 10993 standard series (i.e., ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-12, and ISO 10993-23) and test results met the same acceptance criteria as the predicate devices.

#### Conclusion

The subject devices have the same intended use as the legally marketed predicate devices. Both the subject devices and the predicate devices have identical technological characteristics for lens insertion during cataract surgery. Both utilize a non-preloaded cartridge that is used to fold and position the lens on top of a handheld injector prior to lens delivery. Performance data is available which supports the substantial equivalence of the subject devices to the predicate devices.

510(k) Premarket Notification
RxSight, Inc.

Insertion Devices (Model 63000/63001 and 63002)

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---**510(K) SUMMARY**

The subject devices and their predicates met the same requirements of non-clinical performance testing (simulated surgical manipulation and recovery of properties) in accordance with ISO 11979-3:2012. Additionally, recovery of optical properties and overall surface and bulk homogeneity were tested and met the requirements pre and post lens injection per ISO 11979-2:2014. Biocompatibility testing was performed per relevant parts of ISO 10993 standard series (i.e., ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-12, and ISO 10993-23) and test results met the same acceptance criteria as the predicate devices.

Therefore, the RxSight Insertion Device (Model 63000/63001 and Model 63002) with the proposed changes in cartridge material and shelf-life is substantially equivalent to the RxSight Insertion Devices that were cleared in K231466 and K231838.

---**510(k) Premarket Notification**
**RxSight, Inc.**

**Insertion Devices (Model 63000/63001 and 63002)**