(34 days)
The OmniLight FPL System is intended to be used in the following procedures:
- Hair Removal in all Skin types according to the Fitzpatrick Scale
- Permanent Hair reduction
- Treatment of Vascular Lesions
- Treatment of Pigmented Lesion
- Tattoo Removal
The OmniLight Fluorescent Pulsed Light System delivers pulsed light at wavelengths starting at 515 nanometers. The device consists of three interconnected sections: 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 OmniLight Fluorescent Pulsed Light System did not include performance data or studies to support its substantial equivalence beyond its comparison to predicate devices. The 510(k) Summary explicitly states "Performance Data: None".
Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them because no such study or data was provided in the submission. The FDA cleared this device based on its substantial equivalence to previously cleared predicate devices (ProLite and Plasmalite MPX Pulsed Light System) without requiring new performance data.
§ 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.