Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse

K231011 · Meridian AG · HQF · Sep 12, 2023 · Ophthalmic

Device Facts

• Record ID: K231011
• Device Name: Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse
• Applicant: Meridian AG
• Product Code: HQF · Ophthalmic
• Decision Date: Sep 12, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MERILAS 810 shortpulse laser is indicated for: - Photocoagulation - Iridotomy - Trabeculoplasty - Thermotherapy The MERILAS 532 shortpulse laser is indicated for: - Photocoagulation - Iridotomv - Trabeculoplasty The MERILAS 577 shortpulse laser is indicated for: - Photocoagulation - Iridotomy - Trabeculoplasty

Device Story

Merilas shortpulse laser series (532, 577, 810 nm) are ophthalmic lasers used for photocoagulation, iridotomy, trabeculoplasty, and thermotherapy (810 nm). Devices deliver laser energy to ocular tissues to achieve therapeutic effects. Operated by physicians in clinical settings. Output is controlled laser energy; clinical decision-making relies on physician assessment of ocular pathology. Benefits include precise tissue treatment for various ophthalmic conditions.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on non-clinical information.

Technological Characteristics

Ophthalmic laser system; wavelengths 532 nm, 577 nm, and 810 nm; shortpulse delivery mode; Class II device; product code HOF.

Indications for Use

Indicated for photocoagulation, iridotomy, trabeculoplasty, and thermotherapy (810 only) in patients requiring ophthalmic laser treatment.

Regulatory Classification

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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 12, 2023

Meridian AG % Kevin Walls Principal Consultant Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton. Colorado 80127

Re: K231011

Trade/Device Name: Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HOF Dated: August 12, 2023 Received: August 14, 2023

Dear Kevin Walls:

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

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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 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Claudine H. Krawczyk -S

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

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# Indications for Use

510(k) Number (if known)

#### K231011

Device Name

Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse

#### Indications for Use (Describe)

The MERILAS 810 shortpulse laser is indicated for:

- Photocoagulation
- Iridotomy
- Trabeculoplasty
- Thermotherapy

The MERILAS 532 shortpulse laser is indicated for:

- Photocoagulation
- Iridotomv
- Trabeculoplasty

The MERILAS 577 shortpulse laser is indicated for:

- Photocoagulation
- Iridotomy
- Trabeculoplasty

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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