(55 days)
The Del Sol Blue Light Therapy System is intended to provide photo therapeutic light to the body. The Del Sol Blue Light Therapy System is generally indicated to treat dermatological conditions. The Del Sol Blue Light Therapy System is specifically indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris.
Not Found
I am unable to answer your request. The provided text is a 510(k) clearance letter from the FDA for a medical device (Del Sol Blue Light Therapy system).
While this letter confirms that the device is cleared for market based on substantial equivalence to a predicate device, it does not contain the detailed study information, acceptance criteria, or performance data that you are requesting. Such information would typically be found in the actual 510(k) submission document or a summary thereof, which is not provided in the given text.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, adjudication methods for test sets.
- Information on MRMC studies or standalone algorithm performance.
- Details about the ground truth used or how it was established for training and test sets.
- Sample size for the training set.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 0 2006
Edge Systems, Inc. % Mr. Gary S. Mocnik Regulatory Consultant 24372 McCloud Court Laguna Niguel, California 92677
Re: K061470
Trade/Device Name: Del Sol Blue Light Therapy system 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: May 10, 2006 Received: June 15, 2006
Dear Mr. Mocnik:
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
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Page 2 - Mr. Gary S. Mocnik
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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,
Barbara Buckner
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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510(k) Number (if known):
Del Sol Blue Light Therapy system Device Name:
Indication For Use:
The Del Sol Blue Light Therapy System is intended to provide photo therapeutic The Del Sol Dide Eight Therapy System is generally indicated night to the Dody. The Del Sol Blue Light The Del Sol Blue Light Therapy System is to treat dermatorogrout conditions!
specifically indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris.
Prescription Use
Per 21 CFR 801.109
Over-The-Counter Use_
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buchimp
Division Division of General, Restorative, and Neurological Devices
510(k) Number K061471
§ 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.