(85 days)
The IDS SHINY IPL system is intended for use in Surgical, Aesthetic applications in Dermatology by using filtered Intense Pulsed Light to treat the following conditions with different wavelengths to skin types I-IV.
- Wavelengths: Conditions: 415nm - 950nm Acne, Vulgaris 560nm - 950nm Melasma, Ephelides 640nm - 950nm Acne, Hair Reduction 640nm - 1200nm Hair Reduction 695nm - 1200nm Hair Reduction 755nm - 1200nm Hair Reduction
The SHINY IPL System, using visible rays created by Xenon Lamp through Sapphire which are installed on Hand-piece, and composed Main board, LCD screen, Hand-piece, Cooling system. This device uses computer controlled power supply and filter to generate visible ray pulses of prescribed duration and intensity. This device also equipped the Cooling systems to maintain both the Treatment head / Systems at appropriate and safe temperatures. The visible ray pulses or emission spectra provide therapeutic indications relevant to specific wavelengths emitted from the system. This system has two hand-pieces and each hand-piece has 3 wavelengths to choose from at the end of the Hand-piece there is a sapphire filter. Visible rays are emitted when the button is pressed.
The provided document is a 510(k) summary for the SHINY IPL System. It describes the device, its intended use, and a comparison to a predicate device. However, it does not include detailed information on acceptance criteria for device performance studies or the specific studies conducted to prove the device meets these criteria in the context of clinical effectiveness or algorithm performance (e.g., studies involving human readers or standalone AI performance).
The "Summary of Performance and Safety Testing" section (Page 4, Section 7) broadly states:
"The SHINY IPL System performs as intended based on performance data provided in this submission.
Software: Verification and validation testing of the software confirm that the software version is appropriate for release.
Electrical Safety and Electromagnetic Compatibility: The SHINY IPL System has been tested for electromagnetic compatibility and electrical safety per the applicable recognized consensus standards (IEC 60601-1, IEC 60601-1-2)."
This section focuses on general performance, software validation, and electrical safety/EMC, which are standard engineering and regulatory compliance tests. It does not refer to clinical studies or AI algorithm performance validation.
Therefore, I cannot extract the specific details requested in your prompt regarding acceptance criteria and performance studies related to clinical effectiveness, AI algorithm performance, human reader improvement, or ground truth establishment. The document suggests that the substantial equivalence determination for this IPL system is based on its similarity in design, operational features, and intended use to the predicate device, along with meeting general safety and performance standards, rather than specific clinical trial data demonstrating effectiveness against a predefined acceptance criterion for a medical outcome or AI accuracy.
§ 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.