(279 days)
The A.R.C. Laser Fox Laser System is indicated for retinal and pan retinal photocoagulation, endophotocoagulation and transcleral cyclophotocoagulation for the treatment of: Diabetic Retinopathy Retinal tears and detachment Age related macular degeneration Retinopathy of prematurity Primary open angle glaucoma Refractory glaucoma
Not Found
The provided text is an FDA 510(k) clearance letter for the A.R.C. Laser Fox Laser System and Accessories. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the detailed study parameters requested in your prompt.
The letter primarily focuses on:
- Confirming the device's substantial equivalence to a predicate.
- Listing the regulation number, regulation name, and product code.
- Indicating the general controls provisions of the Act that apply.
- Providing contact information for device-related inquiries.
- Listing the "Indications For Use" for the device, which describes the medical conditions it is intended to treat.
Therefore, I cannot fulfill your request using the provided text. To answer your questions, I would need a clinical study report, a summary of safety and effectiveness data, or a detailed technical submission for the device that outlines its performance evaluation.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 16 2007
Howard Instruments, Inc. % Mr. Jack Howard President 4749 Appletree Tuscaloosa, Alabama 35405
Re: K063104
Trade/Device Name: A.R.C. Laser Fox Laser System and Accessories Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: March 20, 2007 Received: March 21, 2007
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, 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 2 - Mr. Jack Howard
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark H. Milken
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K063104
Device Name: A.R.C. Laser Fox Laser System and Accessories
Indications For Use: The A.R.C. Laser Fox Laser System is indicated for retinal and pan retinal photocoagulation, endophotocoagulation and transcleral cyclophotocoagulation
for the treatment of:
Diabetic Retinopathy Retinal tears and detachment Aqe related macular degeneration Retinopathy of prematurity Primary open angle glaucoma Refractory glaucoma
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 501 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED )
ation (ODE) Concurrence of CDRH, Off.
Mark A Wilkerson
Page 1 of __
(Division Sign-Off Division of General. Restorative, and Neurological Devices
510(k) Number
§ 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.