(164 days)
The Laserex Duo family of dual wavelength ophthalmic lasers are intended for use in the treatment of ocular pathology.
The Laserex Duo is indicated for use in photocoagulation of both anterior and posterior segments of the eye including:
- Retinal photocoagulation and pan retinal photocoagulation of vascular and . structural abnormalities of the retina and choroid including:
- proliferative and nonproliferative diabetic retinopathy; -
- choroidal neovascularization; -
- branch retinal vein occlusion; -
- age-related macular degeneration;
- retinal tears and detachments; -
- retinopathy of prematurity; -
- Iridotomy, iridectomy, suturelysis and trabeculoplasty in angle closure glaucoma . and open angle glaucoma
Not Found
The provided text is a 510(k) summary for the Laserex Duo family of ophthalmic lasers. It describes the device, its intended use, and the FDA's determination of substantial equivalence to a predicate device.
*However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the detailed study parameters you've requested.
This type of FDA clearance letter (510(k) summary) primarily focuses on establishing substantial equivalence to a legally marketed predicate device, not on presenting detailed performance data from new clinical studies against specific acceptance criteria.
Therefore, I cannot provide the requested information based on the given text.
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Image /page/0/Picture/12 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three horizontal lines forming its body and wings. The text "DEPARTMENT OF HEALTH &" is vertically oriented along the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ellex Medical Pty Ltd c/o Kevin Howard Regulatory Officer 82 Gilbert Street Adelaide, SA 5000 Australia
MAR 1 6 2005
Re: K052777
Trade/Device Name: Laserex Duo family of dual wavelength ophthalmic lasers. Including models Integre Duo LP1RG-S, LP1RG-D and Avante Duo LP2RG. Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HQF; GEX Dated: December 19, 2005 Received: December 21, 2005
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 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. 1)rug, 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. Iisting 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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This letter will allow you 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 Office of Compliance at (301) 827-8910. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Egelund - M.D.
Malvina B. Eydelman, M.D. Acting Division 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): K052777
Device Name: Laserex Duo family of dual wavelength ophthalmic lasers. Including models Integre Duo LP1RG-S, LP1RG-D and Avante Duo LP2RG.
Indications for Use:
The Laserex Duo family of dual wavelength ophthalmic lasers are intended for use in the treatment of ocular pathology.
The Laserex Duo is indicated for use in photocoagulation of both anterior and posterior segments of the eye including:
- Retinal photocoagulation and pan retinal photocoagulation of vascular and . structural abnormalities of the retina and choroid including:
- proliferative and nonproliferative diabetic retinopathy; -
- choroidal neovascularization; -
- branch retinal vein occlusion; -
- ﺘ age-related macular degeneration;
- retinal tears and detachments; -
- retinopathy of prematurity; -
- Iridotomy, iridectomy, suturelysis and trabeculoplasty in angle closure glaucoma . and open angle glaucoma
Prescription Use V AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Denis L. MCarthy
Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number K052777
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§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.