(64 days)
The Light for Winkles is an Over-The-Counter handheld device intended for use in the treatment of periorbital wrinkles.
The Light for Wrinkles is a hand-held device with a power output of 65mW/cm2, consisting of low intensity light emitting diodes (LED's) that emit Low and Sub-IR light for direct exposure to the skin. The device components include an LED array of 605nm, 630nm, 660nm, and 855nm wavelengths, a (non-flammable plastic) hand piece housing a printed circuit board upon which the LED's are mounted, single non-timer on/off switch with 5-ohm resistor, receiver jack in the hand piece accommodating a removable power cord and a separate AC to DC (9-volt) power supply. Treatment time is recommended to be 3 minutes and is controlled by the user.
The provided document is a 510(k) summary for the "Light for Wrinkles" device. It does not contain any performance data or a study that proves the device meets specific acceptance criteria in the manner requested.
Instead, the submission for this device relies entirely on the concept of substantial equivalence to a predicate device. The core argument is stated explicitly:
- "Taking into consideration the statement in '5. Substantial Equivalency' above, after an analysis of the safety, indications and intended uses, performance, features, technological properties and methods of operation, LED Intellectual Properties, LLC believes that no significant differences exist between the Light for Wrinkles and the predicate device listed in Section 3, above." (Page 3)
Therefore, I cannot populate the requested table or answer questions about a study that does not exist in this document.
Here's a breakdown of why the information is not present based on the provided text:
- Acceptance Criteria and Reported Device Performance: Not provided. The submission asserts substantial equivalence rather than presenting specific performance metrics against defined criteria.
- Sample size, Data Provenance: No test set was used for this device in this submission, as performance data was not generated.
- Number of experts, qualifications, adjudication method: Not applicable, as no ground truth was established for a test set for this device in this submission.
- MRMC comparative effectiveness study: Not conducted or mentioned.
- Standalone performance study: Not conducted or mentioned for this device.
- Type of ground truth: Not applicable.
- Sample size for training set: Not applicable, as this is not an AI/ML device and no training set was used.
- How ground truth for training set was established: Not applicable.
Summary of Device and 510(k) Approach:
- Device Name: Light for Wrinkles
- Intended Use: Over-The-Counter handheld device for treatment of periorbital wrinkles.
- Predicate Device: LED Intellectual Properties, LLC - Anti-Wrinkle Light, Model AAL
- Basis for Clearance: Substantial Equivalence. The applicant states that the device has "the exact same technological characteristics including design, materials, power output (65nM/cm2), the exact same wavelengths, delivery system and power transformer" as the predicate.
- Performance Data in Submission: None provided; reliance on equivalence to predicate device.
Conclusion: The 510(k) submission for "Light for Wrinkles" did not include a study with acceptance criteria and device performance data. Its clearance was based on its substantial equivalence to a previously cleared predicate device, meaning the FDA did not require new performance data within this specific 510(k) application due to the asserted identicality with the predicate.
§ 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.