(73 days)
VISULAS 532s (K013402)
Not Found
No
The description focuses on the hardware components, laser delivery mechanisms, and basic parameter adjustments. There is no mention of AI, ML, or any features that would suggest learning, adaptation, or complex data analysis.
Yes
The device is indicated for use in medical procedures (retinal photocoagulation, iridotomy, laser trabeculoplasty) to treat medical conditions.
No
Explanation: The MERILAS 532a is indicated for use in retinal photocoagulation, iridotomy, and laser trabeculoplasty, which are all treatment procedures, not diagnostic ones. The device description also details how it delivers laser treatment, not how it diagnoses conditions.
No
The device description clearly details hardware components such as a base laser unit, delivery devices (slit lamp adapter, indirect ophthalmoscope, endo fiber), a display unit, sensors, a laser diode, an Nd:YVO laser, a KTP crystal, optical fiber, and mechanical components made of aluminum, sheet metal, and copper. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The MERILAS 532a is a laser system used for treating conditions in the eye (retinal photocoagulation, iridotomy, laser trabeculoplasty). It directly interacts with the patient's tissue.
- Lack of Sample Analysis: The description does not mention any analysis of biological samples. The device delivers laser energy to the eye for therapeutic purposes.
Therefore, the MERILAS 532a falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MERILAS 532a is indicated for use in retinal photocoagulation, iridotomy and laser trabeculoplasty.
Product codes
HQF
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospitals, clinics, consulting rooms
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
VISULAS 532s (K013402)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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.
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 Device
VISULAS 532s (K013402) | New device
MERILAS 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 adapter
Endo fiber
Laser indirect ophthalmoscope
Laser slit lamp | Slit lamp adapter
Endo fiber
Laser 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 use
in photocoagulating ocular tissues in the
treatment of diseases of the eye.
The laser energy is delivered via either
transpupillary delivery or intraocular
endroprobe delivery | The MERILAS 532a is indicated for use in
retinal photocoagulation, iridotomy and laser
trabeculoplasty. |
| Design | Base Laser unit with detachable display unit
and delivery device options. | Base Laser unit with detachable display unit
and delivery device options. |
| Controls | Controls on the base laser unit and on the
detachable display unit. | Controls on the base laser unit and on the
detachable display unit. |
| Display | Parameter monitoring and selection on display
panel. | Parameter monitoring and selection on display
panel. |
| Hardware | μP-based system control
touch sensitive display unit | μP-based system control
touch 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.
4
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
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