(114 days)
The Laserex LP4532 Ophthalmic Laser is intended for use in the treatment of ocular pathology
The Laserex LP4532 is indicated for use in photocoagulation of both anterior and posterior segments of the eye including:
- Retinal photocoagulation, pan retinal photocoagulation and intravitreal endophotocognilation of vascular and structural abnormalities of the retina and choroid including:
- proliferative and nonproliferative diabetic retinopathy:
- choroidal neovascularization;
- branch retinal vein occlusion;
- age-refated macular degeneration;
- retinal tears and detachments;
- retinopathy of prematurity;
- macular grid;
- macular focal;
- Iridotomy, tridectorny, suturelysis and trabeculoplasty in angle closure glaucoma and open angle glaucoma
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Ellex Medical Pty. Ltd. regarding their Laserex LP4532 Ophthalmic Laser. This document is a regulatory approval letter and an "Indications for Use" statement, not a scientific study report or clinical trial summary.
Therefore, the document does not contain the information requested about acceptance criteria, device performance, study details (sample sizes, data provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, or training set details.
The letter confirms that the FDA has reviewed the 510(k) submission and determined the device to be substantially equivalent to legally marketed predicate devices for the stated indications for use. It lists the medical conditions the laser is intended to treat, such as various retinal pathologies and glaucoma treatment procedures, but it does not provide data or a study description to prove performance against specific acceptance criteria.
To answer your request, a different type of document, such as a clinical study report or a summary of safety and effectiveness, would be needed.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kevin Howard Regulatory Officer Ellex Medical Pty. Ltd. 74 to 86 Gilbert Street Adelaide SA 5000
Re: K041598
Austrailia
Trade/Device Name: Laserex LP4532 Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: II Product Code: HQF Dated: September 10, 2004 Received: September 16, 2004
Dear Mr. Howard:
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 for assessment 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.
OCT 6 - 2004
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Page 2 -- Mr. Kevin Howard
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter whi anow you to begin manusing of substantial equivalence of your device to a legally premaired notheadon: "The PDA miding of east one."
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 IT you desire specific acvice 101 Jour as 1) 276-0115. Also, please note the regulation entitled, Connact the Office of Compunes to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
CSW, LICSW, Ph.D., M.P.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):K041598
Device Name: Laserex LP4532
Indications for Use:
The Laserex LP4532 Ophthalmic Laser is intended for use in the treatment of ocular pathology
The Laserex LP4532 is indicated for use in photocoagulation of both anterior and posterior segments of the eye including:
- Retinal photocoagulation, pan retinal photocoagulation and intravitreal endophotocognilation of vascular and structural abnormalities of the retina and choroid including:
- proliferative and nonproliferative diabetic retinopathy:
- choroidal neovascularization;
- branch retinal vein occlusion;
- age-refated macular degeneration;
- retinal tears and detachments;
- retinopathy of prematurity;
- macular grid;
- macular focal;
- Iridotomy, tridectorny, suturelysis and trabeculoplasty in angle closure glaucoma and open angle glaucoma
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
niriam (. Provos (Division Sign-Off) Division of General, Restorative. and Neurological Devices
Prescription Use
(Per 21 CFR 801.109)
510(k) Number K041598
(Optional Format 1-2-96)
§ 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.