(60 days)
The Nanolite Skin Care System is indicated to treat pigmented lesions.
The Nanolite Skin Care System is a light-based device that uses LED to stimulate and regenerate skin cells. The device delivers red light at 640 nm.
The principal parts of the device are: the base that contains the power supply; a LED module containing surface mount device chip LEDs; one arm attached to the LED module to be positioned for patient treatment; and a control unit consisting of an LCD panel with a touchscreen display.
The provided text is a 510(k) Summary for the Nanolite Skin Care System and a letter from the FDA regarding its substantial equivalence. It describes the device, its intended use, and its similarities to a predicate device. However, this document does not contain information about a study that proves the device meets specific acceptance criteria.
The 510(k) pathway is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials to prove efficacy or meet specific performance criteria against pre-defined metrics. The document states that "Although there are some differences in the technological characteristics of the Nanolite Skin Care System and its predicate devices, those differences do not raise new questions of safety or efficacy." This implies that new studies demonstrating performance against acceptance criteria were not deemed necessary for this submission.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document does not describe acceptance criteria, a study, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for training or testing sets.
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JUN 20 2006
510(k) Summary of Safety and Effectiveness
Applicant: Nanolite Technology, Inc.
Address: 21250 Hawthorne Blvd., Suite 500 Torrance, California 90503
Phone: 909-598-5778
Fax: 909-598-7369
Contact Person: Hueng Khon Kim
Summary Preparation Date: May 17, 2006
Device Trade Name: Nanolite Skin Care System
Device usual name: Low level light therapy device
Device Classification:
Regulatory Class: Class II
Product Code: GEX
Classification Panels: General and Plastic Surgery
Regulation Number: 21 C.F.R. 878.4810 (Laser surgical instrument for use in general and plastic surgery and in dermatology)
Note: The Nanolite Skin Care System is not a laser product; however, the applicant believes that this classification is the most applicable.
Description of the Device:
The Nanolite Skin Care System is a light-based device that uses LED to stimulate and regenerate skin cells. The device delivers red light at 640 nm.
The principal parts of the device are: the base that contains the power supply; a LED module containing surface mount device chip LEDs; one arm attached to the LED module to be positioned for patient treatment; and a control unit consisting of an LCD panel with a touchscreen display.
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The software in the LCD panel is preprogrammed to provide for twenty minutes of exposure time to LED lights per treatment. During each treatment, the lights are turned on and off to prevent desensitization of the skin area that is being treated and to increase the stimulative effects of the energy from the LED.
The Nanolite Skin Care System generates output power equal to 170 mW/cm² from each LED. Since Nanolite has 6 LEDs per square centimeter, it generates total power dissipation per square meter of 1020 mW/cm². The device software is programmed to control the output power to create a standard dose of approximately 90J/cm² tho each treatment.
Predicate Devices:
The Nanolite Skin Care System is substantially equivalent to Omnilux Revive manufactured by Photo Therapeutics Limited (K030426).
Indications:
The Nanolite Skin Care System is indicated to treat pigmented lesions.
Substantial Equivalence:
The Nanolite Skin Care System and the predicate device are all light devices that use light emitting diodes to treat dermatological conditions by exposing the surface of the skin to light at precise wavelengths. They have the same intended use and general indications for use, are similarly designed, and have similar principles of operation, performance and technological characteristics. Although there are some differences in the technological characteristics of the Nanolite Skin Care System and its predicate devices, those differences do not raise new questions of safety or efficacy. Therefore, the Nanolite Skin Care System is substantially equivalent.
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JUN 20 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nanolite Technology, Inc. c/o Daniel W. Lehtonen Intertek Testing Services 2307 East Aurora Rd., Unit B7 Twinsburg, OH 44087
Re: K061117 Trade/Device Name: Nanolite Skin Care 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: June 2, 2006 Received: June 5, 2006
Dear Mr. Lehtonen:
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. Daniel W. Lehtonen
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,
Herber Hemus us
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 Statement
510(k) Number: K061117
Device Name: Nanolite Skin Care System™
Indications for Use:
The Nanolite Skin Care System is indicated to treat pigmented lesions.
Prescription Use _ X (per 21 CFR 801.109)
ﻟﻜﻢ
OR
Over-the-Counter Use
(Please do not write below this line - Continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulus Resmer
(Division Sign-Off Division of General, Restorative, and Neurological Devices
06 111 510(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.