(59 days)
OPERA LEBODY is an over the counter device that is intended for the use in the treatment of full face wrinkles.
The OPERA LEBODY is a device which allows emission of LED light in the red (630nm) and IR (830nm) spectrum onto the face, which induces photobiological effect to the face for reduction of wrinkle. OPERA LEBODY includes the mask that contains LEDs on the inner surface, the controller which turns on and off the device, a cradle that holds the face mask, a pouch that keeps the product, and USB cable that delivers electrical power to the controller for operation or for charging the battery contained in the controller.
The user wears a mask and operates OPERA LEBODY using the controller. The device will automatically turn off after 10 minutes. Emitted light from LEDs are not intended for ocular or ophthalmic treatment. To prevent irradiation of LED lights to eyes during the treatment, OPERA LEBODY has protective eye guide which blocks light energy from LEDs.
This document is a 510(k) summary for the OPERA LEBODY device, which is an over-the-counter device intended for the treatment of full-face wrinkles. The document details the device's characteristics and its substantial equivalence to predicate devices, but it does not include any study data or acceptance criteria related to a clinical performance study demonstrating the device’s effectiveness in reducing wrinkles.
The "Performance Data" section primarily addresses non-clinical tests related to safety, electrical compatibility, and photobiological safety, rather than clinical efficacy.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study design from the given text.
The information provided only relates to:
- Non-clinical/bench testing performed: Measurement of wavelength, average output power, and total irradiance of treatment LEDs. Safety of lamps and lamp systems, electromagnetic compatibility, electrical safety, photobiological safety, risk management, and usability were tested according to various IEC and ISO standards.
- Biocompatibility: The patient-touching parts are made of silicone and ABS plastics, which are used in other medical devices without biocompatibility risk.
§ 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.