← Product Code [OOE](/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE) · K223838
# Catalys Precision Laser System (K223838)
_Amo Manufacturing USA, LLC · OOE · Apr 12, 2023 · Ophthalmic · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K223838
## Device Facts
- **Applicant:** Amo Manufacturing USA, LLC
- **Product Code:** [OOE](/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE.md)
- **Decision Date:** Apr 12, 2023
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.4390
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic
- **Attributes:** Therapeutic
## Intended Use
The Catalys™ Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.
## Device Story
Ophthalmic surgical laser system used in hospitals, ASCs, and surgeon offices. Employs femtosecond laser technology with integrated Spectral Domain Optical Coherence Tomography (OCT) for real-time imaging. System uses common optical path for OCT and treatment laser, ensuring co-registered imaging and treatment beams. Surgeon operates system via graphical user interface to define incisions based on OCT-visualized ocular anatomy (anterior chamber, lens, cornea). Laser pulses create localized plasma and cavitation to perform capsulotomy, lens fragmentation, and corneal incisions. Software updates include advanced astigmatism management, Stevens nomogram, Toric Mark Axis Calculator, and expanded pre-op data import capabilities (e.g., IOLMaster 700). System facilitates efficient lens removal and precise corneal incisions, potentially improving surgical outcomes.
## Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, software verification/validation, and regression testing.
## Technological Characteristics
Class 4 femtosecond laser (1030 nm wavelength); Spectral Domain OCT (820-930 nm source); pulse duration <600 fs; max pulse energy 10 µJ; repetition rate 9-120 kHz. Includes Liquid Optics™ Interface (single-use, sterile). Software-controlled via microprocessor. Connectivity includes pre-op exam import. Complies with 21 CFR 1040.10/1040.11 and ISO 15004-2:2007.
## Regulatory Identification
An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.
## Predicate Devices
- CATALYST™ Precision Laser System ([K200056](/device/K200056.md))
## Reference Devices
- Cassini pre-op device
- IOLMaster 700 pre-op device
## Submission Summary (Full Text)
> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
April 12, 2023
AMO Manufacturing USA, LLC Laarni Ricafort Manager, Regulatory Affairs 510 Cottonwood Drive Milpitas, CA 95035
Re: K223838
Trade/Device Name: Catalys™ Precision Laser System Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: OOE Dated: March 10, 2023 Received: March 14, 2023
## Dear Laarni Ricafort:
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 (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 located 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.
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
{1}------------------------------------------------
(21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-devicereporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
J Angelo Green -S
Image /page/1/Picture/6 description: The image contains the letters '-S' on the left side of the image. To the right of the letters is the acronym 'FDA' in a light blue color. The letters are large and take up a significant portion of the image.
for Tieuvi Nguyen, Ph.D. 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
{2}------------------------------------------------
## Indications for Use
510(k) Number (if known) K223838
Device Name CATALYSTM Precision Laser System
#### Indications for Use (Describe)
The CATALYS™ Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/ incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
# 510(k) SUMMARY
The following 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92
| 510(k) Summary: | K223838 |
|-----------------|---------|
|-----------------|---------|
[807.92(a)(1)] Submitter Information
| Sponsor/Submitter: | AMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035 USA
Phone 408-273-5166
Fax:408 273-5966 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Laarni Ricafort
Manager, Regulatory Affairs
Email: lricafor@its.jnj.com
Phone: 408-273-4016
Fax: :408 273-5966 |
| Date Summary Prepared: | April 10, 2023 |
[807.92(a)(2)] Name of Device
| Device Trade Name: | CATALYST™ Precision Laser System |
|------------------------|----------------------------------|
| Common Name: | Opthalmic laser |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 886.4390 |
| Classification Name: | Opthalmic Femtosecond Laser |
| Product Code: | OOE |
[807.92(a)(3)] Legally Marketed Devices
| Predicate Device: | CATALYST™ Precision Laser System
K200056; cleared May 18, 2020 |
|-------------------|-------------------------------------------------------------------|
|-------------------|-------------------------------------------------------------------|
{4}------------------------------------------------
### [807.92(a)(4)] Device Description
Catalys™ Precision Laser System ophthalmic surgical laser system Device Description: used in healthcare facilities such as hospitals. Ambulatory Surgerv Centers (ASCs) and surgeon office settings. The System is an electromedical device which contains software. System components include a single-use Liquid Optics™ Interface and optional Mobile Patient Bed. The Catalys™ Precision Laser System (also referred to as the Catalys™ System or System) is an ophthalmic surgical laser system indicated for use in cataract surgery to create a precise anterior capsulotomy and/or to effect lens fragmentation, thus facilitating efficient lens removal. The System also creates single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. The System employs femtosecond ("FS") laser technology with integrated Optical Coherence Tomography ("OCT"), all of which are controlled and monitored by dedicated electronics. The System utilizes a common optical path for the OCT and femtosecond treatment laser (including the threedimensional scanner and Liquid Optics™ [patient] Interface). As such, the beams are intrinsically co-registered and provide for precise overlap between imaging and treatment beams. Ocular surfaces recognized by the system software include anatomy within the anterior chamber, such as the anterior and posterior corneal surfaces and the anterior and posterior surfaces of the crystalline lens. Detailed axial or sagittal cross-sectional views are available via OCT, to demarcate proposed incisions versus adjacent ocular structures (for example, iris, pupil and limbus). The Catalys™ Precision Laser System laser classification per 21 CFR 1040.10 and 1040.11 is Class 4.
### [807.92(a)(5)] Intended Use
The Catalys™ Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.
Indications for Use:
{5}------------------------------------------------
## The Catalys™ Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior Difference in capsulotomy, phacofragmentation, and the creation of single Indications from plane and multi-plane arc cuts/incisions in the cornea, each of Predicate Device which may be performed either individually or consecutively during the same procedure. The subject device and the predicate device have the same indications for use. [807.92(a)(6)] Technical Characteristics The subject Catalys Precision Laser System is unchanged in regard to its technological characteristics, indications for use, and intended uses. The software revisions for the subject device include updates to the graphical user interface and host to improve the efficiency of the workflow as well as the addition of software modules to support the import of patient exams and iris registration. The revisions in the modified device are constrained to only software changes, of which most are related to advanced astigmatism management and additional updates to currently implemented features. Technological Software verification and validation testing in addition to bench Characteristics: testing was performed to verify the ability of the software to meet its intended use and to ensure that no adverse effects have been introduced due to the software change. This testing included subsystem level verification and regression testing as well as system validation using the latest software, Mobile Patient Bed, and Liquid Optics Interface. The following table provides a comparison of the predicate device and subject device for the purpose of demonstrating substantial equivalence to the predicate device for its indication for use, intended use, technological characteristics and added new features.
#### Similarities and Differences Between Cleared Predicate Device and Subject Device
| Attribute | Predicate Device
Catalys Precision Laser
System | Subject Device
Catalys Precision Laser
System |
|--------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| 510(k) Number | K200056 | TBD |
| Regulation Number | 886.4390 | Same |
| Attribute | Predicate Device
Catalys Precision Laser
System | Subject Device
Catalys Precision Laser
System |
| Regulation Name | Ophthalmic Laser | Same |
| Regulatory Class | Class II | Same |
| Product Code | OOE | Same |
| Indications for Use | The Catalys™ Precision Laser
System is indicated for use in
patients undergoing cataract
surgery for removal of the
crystalline lens. Intended uses in
cataract surgery include anterior
capsulotomy,
phacofragmentation, and the
creation of single plane and
multi-plane arc cuts/incisions in
the cornea, each of which may
be performed either individually
or consecutively during the
same procedure. | Same |
| System Type | Ophthalmic Femtosecond Laser
with Spectral Domain OCT | Same |
| Laser Mechanism of Action | Plasma, Cavitation | Same |
| Treatment Laser Wavelength
(nm) | $1030 \pm 5$ | Same |
| Output Power, Max | Per ISO 15004-2:2007 limits | Same |
| Maximum Pulse Energy (µJ) | 10 | Same |
| Repetition Rate (kHz) | 9-120 | Same |
| Pulse Duration (fs) | < 600 | Same |
| Spot Size; diameter (µm) | 5 | Same |
| System controls | Microprocessor with Graphical
User Interface | Same |
| Patient Contact Interface | Suction-ring type interface
devices (marketed as Liquid
Optics™ Interface) Sterile and
Single-use | Same |
| Attribute | Predicate Device
Catalys Precision Laser
System | Subject Device
Catalys Precision Laser
System |
| LOI Suction Ring Seal
Diameters (mm) | LOI
External (mm): 21.6
Internal (mm): 14.1 | Same |
| | LOI-12
External (mm):19
Internal (mm):12 | Same |
| | 0180-1401
External (mm): 21.6
Internal (mm): 14.1 | Same |
| | 0180-1201
External (mm): 19
Internal (mm): 12 | Same |
| OCT Axial Resolution (µm) | 30 | Same |
| OCT transverse Resolution
(µm) | 15 | Same |
| Scan speed (A-scans/sec) | 1000 | Same |
| A-scan depth (nm) | 2 | Same |
| Optical Source | 820-930 | Same |
| Optical Power | ANSI Class 1 < 3.48mW at
cornea | Same |
| Iris Imaging | Live iris view | Same |
| Trajectory Timing
Synchronization | FPGA coordinates from one
non-reentrant VI | Same |
| Communication Method for
Watchdog for Host PC with
the Mobile Patient Bed
Pairing | Direct FPGA Interface | Same |
| Attribute | Predicate Device
Catalys Precision Laser
System | Subject Device
Catalys Precision Laser
System |
| Software Features | Built-in Nomogram | Addition of Stevens nomogram |
| | Toric Alignment Marks | Toric Mark Axis Calculator |
| | Lens Fragmentation Alignment | Additional Nomogram
customizations |
| | Pre-op Manual Entry | |
| | Pre-op Import (from Cassini
pre-op device) | Pre-op Import (from IOLMaster
700 pre-op device) |
| | Iris Registration (built by
Cassini Technologies) | Iris Registration (built by
Johnson and Johnson) |
{6}------------------------------------------------
{7}------------------------------------------------
{8}------------------------------------------------
# [807.92(b)(1)] Determination of Substantial Equivalence
| | The cOS 7.0 software within the subject device was subjected to
hardware and software bench tests, in conjunction with simulated
use testing. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Software-specific bench testing of the CatalysTM System was
conducted to demonstrate the System's ability to meet all
intended design specifications related to the software design |
| Non-Clinical
Performance Data: | changes. |
| | Bench testing of the predicate device is directly applicable to the
subject device as there are no significant changes to the subject
device other than the design changes resident in the software. |
| | Bench testing, when coupled with software regression testing,
verification and validation testing presented for the subject
device, including regression testing provides reasonable
assurance that the System remains safe and effective for its
intended use and furthermore, that it is substantially equivalent to
the identified predicate device |
{9}------------------------------------------------
| Clinical Performance
Data: | Clinical Data was deemed not necessary for the Catalys™
Precision Laser System. The performance data demonstrated that
the device performs as intended.
The subject device does not include any changes to the
indications for use or intended use of the predicate device. It does
not introduce any new harms or unacceptable risks, and therefore
does not require clinical testing to assess safety and performance
or to demonstrate equivalence. |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| [807.92(b)(3)] Conclusion | |
| Conclusions from Non-
Clinical and Clinical
Tests: | The subject Catalys Precision Laser System is substantially
equivalent to the currently cleared Catalys Precision Laser
System. The subject Catalys Precision Laser System is
substantially equivalent to the predicate in terms of indications
for use, technological characteristics and fundamental scientific
technology. The mechanism of laser cutting is the same for both
systems, in that the ultra-short laser pulses create a highly
localized plasma and subsequent cavitation event that, when
controlled by a computerized scanning system, direct the laser
beam through a three-dimensional pattern to produce a precise
capsulotomy, fragment the crystalline lens and create arc
cuts/incisions in the cornea. |
---
**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K223838](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K223838)
**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).
**Cite:** Innolitics at https://innolitics.com