(61 days)
The Apollo Mini-IPL System is indicated for use skin types I-IV according to the Fitzpatrick Scale for the following indications: Hair Removal (650nm filter), Permanent hair reduction (650nm filter), Treatment of vascular lesions (510nm filter), Treatment of benign pigmented lesions (510nm filter), Mild to Moderate inflammatory acne (450nm filter).
The Apollo Mini IPL System delivers pulsed light at wavelengths starting at 450-1200nm nanometers. The device consists of the cabinet, which houses the power supply, the cooling system and the microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide.
The provided text is a 510(k) Summary for the Apollo Mini IPL System. This document outlines the device's intended use and claims substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria.
The "Performance Data" and "Results of Clinical Study" sections explicitly state "None." This means that Sandstone Medical Technologies, LLC did not submit performance data or clinical study results with their 510(k) application to demonstrate the Apollo Mini IPL System met specific acceptance criteria. Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device's performance based on the input text.
§ 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.