The delivery method can be altered by exchanging the appropriate delivery device and connecting it to the base laser unit. The Autokey connector which belongs to each delivery device ensures that the base laser unit always gets the necessary information about the attached delivery device. The required delivery device has to be connected to the base laser unit before turning on the base laser unit.

During the start up procedure the MERILAS 532« identifies the attached delivery device and internally sets the appropriate parameters. The MERILAS 532α laser itself has built in sensors which do not allow the laser to fire if the delivery device fitted is not suitable in anwav.

For better viewing of the status of the laser unit when space is limited the display unit including the input devices can be removed from the base laser unit and placed on a more convenient space where good access as well as good viewing is possible. The maximum distance the display unit can be placed away from the base laser unit is 1 m due to maximum cable length.

After adjusting the desired parameters on the display of the base laser unit the treatment mode can be selected. In the treatment mode the red aiming beam (635 nm), generated by a laser diode, gets started and indicates the user to which area the treatment beam will be released. The physician selects the target tissue by aiming the red aiming beam to the desired tissue before releasing the treatment pulse.

The treatment laser is a diode pumped Nd: YVO laser which gets frequency doubled by using a KTP crystal. It is radiating at 532 nm. The transmission of the laser light gets achieved by focusing the laser light into an optical fiber and transmitting it to the delivery device. Laser power up to 2.5 W can be delivered out of the fiber. The laser delivery time can be adjusted from 10 ms up to 5 s.

The system can be operated from a 90-260 VAC, 50/60Hz single-phase power outlet. The mechanics of the MERILAS 532« is build out of anodized aluminium, painted sheet metal, and copper.

The optional slit lamp adapter SLA-BMBQ guides the laser beam from the laser unit into the illumination set of a slit lamp and focuses to the desired treatment area. The diameter of the spot can be adjusted in a range from 50 um to 5 mm by turning the dial wheel at the slit lamp adapter.

The mechanics of the SLA-BMBQ is build out of anodized aluminium.

AI/ML Overview

This document is a 510(k) summary for the MERILAS 532α Ophthalmic Surgical Laser, confirming its substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through testing with human readers or standalone algorithm performance.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample size used for the test set and data provenance.
Number and qualifications of experts for ground truth.
Adjudication method.
MRMC comparative effectiveness study results.
Standalone algorithm performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

This document focuses on regulatory clearance based on substantial equivalence to an existing device, not on specific performance studies against pre-defined acceptance criteria for a new clinical or AI-driven application.

Summary

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K072823

510(k) Summary for the MERILAS 532x Ophthalmic Surgical Laser

Name and Address of Sponsor and Manufacturer

MERIDIAN AG Bierigutstrasse 7 Thun 3608 Switzerland Phone +41 33 334 11 11 Fax +41 33 334 11 19

DEC 1 4 2007

Establishment Registration Number

8030988

Name and Address of Official Correspondent

Regulatory Insight, Inc. 13 Red Fox Lane Littleton, Colorado 80127 Contact: Mr. Kevin Walls, RAC Telephone: 720-962-5412 Fax: 720-962-5413 Email: kevin@reginsight.com

Device Name

Trade Name: MERILAS 532α Common Name: Ophthalmic laser Classification Name: Ophthalmic laser

Classification, Panel and Product Code

Class II, Ophthalmic, HQF

Indications for Use

The MERILAS 532a is indicated for use in retinal photocoagulation, iridotomy and laser trabeculoplasty.

Device Description

The methods for delivery of the laser treatment beam to the desired tissue in the eye are:

Slit lamp delivery device (also identified as: slit lamp adapter) such as the SLA-. BMBQ
Laser indirect ophthalmoscope .
. Endo fiber

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The system can be operated from a 90-260 VAC, 50/60Hz single-phase power outlet. The mechanics of the MERILAS 532« is build out of anodized aluminium, painted sheet metal, and copper.

The mechanics of the SLA-BMBQ is build out of anodized aluminium.

Substantial Equivalence

The MERILAS 532x is substantially equivalent to the following legally marketed device. which has been granted marketing clearance by FDA:

Carl Zeiss VISULAS 532s

A side-by-side comparison between the Carl Zeiss VISULAS 532s and the MERILAS 532a is provided below.

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Side-by-side comparison:

Area/Parameter	Predicate DeviceVISULAS 532s (K013402)	New deviceMERILAS 532α
Laser type	Frequency doubled Nd:YVO	Frequency doubled Nd:YVO
Pumping	Diode	Diode
Wavelength	532 nm	532 nm
Cooling	Air	Air
Max. power	1500 mW	2500 mW
Aiming beam	620-650 nm	625-655 nm
Delivery	Slit lamp adapterEndo fiberLaser indirect ophthalmoscopeLaser slit lamp	Slit lamp adapterEndo fiberLaser indirect ophthalmoscope
Power requirements	400 W	250 W
Voltage requirements	90-264 VAC	90-260 VAC
Weight	15 kg	7 kg
Indications for use	The VISULAS 532s laser is intended for usein photocoagulating ocular tissues in thetreatment of diseases of the eye.The laser energy is delivered via eithertranspupillary delivery or intraocularendroprobe delivery	The MERILAS 532a is indicated for use inretinal photocoagulation, iridotomy and lasertrabeculoplasty.
Design	Base Laser unit with detachable display unitand delivery device options.	Base Laser unit with detachable display unitand delivery device options.
Controls	Controls on the base laser unit and on thedetachable display unit.	Controls on the base laser unit and on thedetachable display unit.
Display	Parameter monitoring and selection on displaypanel.	Parameter monitoring and selection on displaypanel.
Hardware	μP-based system controltouch sensitive display unit	μP-based system controltouch sensitive display unit
Anatomical sites	Eye	Eye
Where used	Hospitals, clinics, consulting rooms	Hospitals, clinics, consulting rooms
Slit lamp adapter	VISULINK 532	SLA-BMBO

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircling the eagle. The text is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2007

Meridian AG c/o Kevin Walls, Principle Consultant Regulatory Insight, Inc 13 Red Fox Lane Littleton, CO 80127

Re: K072823

Trade/Device Name: MERILAS 532α Ophthalmic Surgical Laser Regulation Number: 21 CFR 886. 4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HQF Dated: November 21, 2007 Received: November 23, 2007

Dear Mr. 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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page feet with and World to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Egolms, m

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K072823

Device Name: MERILAS 532α

Indications for Use: The MERILAS 532a is indicated for use in retinal photocoagulation, iridotomy and laser trabeculoplasty.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Deceh 12/11/2007
Division Sign Off

(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number K072823

Page 1 of 1

Regulation Number and Section

§ 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.