(225 days)
No
The device description focuses on the laser technology and its physical parameters. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies are focused on non-clinical testing, biocompatibility, software verification/validation, and electrical safety, not on the performance of an AI/ML algorithm.
Yes
The device is intended for use in photodisrupting ocular tissue in the treatment of diseases of the eye. This direct treatment of a disease makes it a therapeutic device.
No
The device description clearly states its purpose is for "photodisruption treatments of diseases of the eye," indicating it is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it uses a Q-switched, flashlamp-pumped solid-state laser and describes physical components like a gain medium and laser source, indicating it is a hardware device with integrated software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- VISULAS yag Function: The VISULAS yag is a laser device that directly interacts with and modifies ocular tissue within the patient's eye. It performs procedures like posterior capsulotomy and iridotomy.
- Lack of Specimen Analysis: The device does not analyze any biological specimens taken from the patient.
Therefore, based on its intended use and how it functions, the VISULAS yag is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
VISULAS yag is intended for use in photodisrupting ocular tissue in the treatment of diseases of the eye, including Posterior capsulotomy, Iridotomy and Posterior Membranectomy.
This device is for Prescription Use (Rx) only.
Product codes
HQF
Device Description
VISULAS yag uses a Q-switched, flashlamp-pumped solid-state laser for photodisruption treatments of diseases of the eye, including posterior capsulotomy, iridotomy and membranectomy. Laser radiation is generated by means of a neodymium-doped yttrium aluminum garnet (Nd:YAG) gain medium inside the laser source. The emitted laser radiation with a near-infrared wavelength of \ = 1064 nm has a pulse duration of
§ 886.4390 Ophthalmic laser.
(a)
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.(b)
Classification. Class II.
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September 22, 2023
Carl Zeiss Meditec Inc Tanesha Bland Sr. Regulatory Affairs Specialist 5300 Central Parkway Dublin, California 94568
Re: K230350
Trade/Device Name: VISULAS yag Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF Dated: August 16, 2023 Received: August 16, 2023
Dear Tanesha Bland:
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 (21 CFR Part
1
801); medical device 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-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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-device-safety/medical-device-reportingmdr-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,
Bennett Digitally signed by Bennett N. ﮯ Walker -S Date: 2023.09.22 Walker -S 10:23:07 -04'00'L
for Claudine Krawczyk Acting 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
2
Indications for Use
510(k) Number (if known) K230350
Device Name VISULAS yag
Indications for Use (Describe)
VISULAS yag is intended for use in photodisrupting ocular tissue in the treatment of diseases of the eye, including Posterior capsulotomy, Iridotomy and Posterior Membranectomy.
This device is for Prescription Use (Rx) only.
| 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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |||
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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In accordance with 21 CFR 807.92 the 510(k) Summary for the VISULAS yag is provided below.
1. SUBMITTER
| Applicant: | Carl Zeiss Meditec Inc
5300 Central Parkway
Dublin, CA
USA |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Correspondent | Tanesha Bland
Sr. Regulatory Affairs Specialist
Carl Zeiss Meditec, Inc.
5300 Central Parkway Dublin, CA 94568
(925) 216-7963 Phone
E-mail: tanesha.bland@zeiss.com (preferred) |
| Secondary Correspondent | Ling Ren
Regulatory Affairs Manager
Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
07745 Jena, Germany |
Date Prepared: September 22, 2023
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2. SUBJECT DEVICE
| Device Trade Name: | VISULAS yag |
|---|---|
| Classification: | 21CFR886.4390 laser, Ophthalmic |
| Regulatory Class: | II |
| Product Code: | HQF |
3. PREDICATE DEVICE
| Predicate Device: | Ellex YAG Laser (Ultra Q, Ultra O Reflex) (K212630) |
|---|---|
| Classification: | 21CFR886.4390 Ophthalmic Laser |
| Regulatory Class: | ﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ |
| Product Code: | HOF |
4. DEVICE DESCRIPTION
VISULAS yag uses a Q-switched, flashlamp-pumped solid-state laser for photodisruption treatments of diseases of the eye, including posterior capsulotomy, iridotomy and membranectomy. Laser radiation is generated by means of a neodymium-doped yttrium aluminum garnet (Nd:YAG) gain medium inside the laser source. The emitted laser radiation with a near-infrared wavelength of \ = 1064 nm has a pulse duration of