(93 days)
The LED Lip Perfector (Model: ZC-05) is an Over-the-Counter (OTC) device intended to treat fines and wrinkles and increase in circulation within the perioral region.
The LED Lip Perfector (Model: ZC-05) is an over-the-counter light-emitting diode (LED) device that emits energy for dermatology to treat fine lines and increase circulation within the perioral region. The device contains four types of LEDs: 605nm, 630nm, and 850nm The LED Lip Perfector components include the main device, charging base, power cord, alternative mouthpiece, user manual, and storage bag. There is only one button on the top edge of the main unit. Short press the power button to turn on the device, and long press the power button to turn off the device. This device only has one treatment mode. The LED Lip Perfector is applied to the skin to ensure consistent light administration during each treatment. The device is sold Over the Counter (OTC).
The provided text is a 510(k) summary for the LED Lip Perfector (Model: ZC-05). It focuses on demonstrating substantial equivalence to a predicate device through comparison of features and adherence to recognized standards. It does not contain information about acceptance criteria or a study proving device performance in the context of clinical effectiveness or statistical superiority/non-inferiority.
Specifically, the document states: "The LED Lip Perfector (Model: ZC-05) has been evaluated the safety and performance by lab bench testing as following:" and then lists a series of recognized standards (e.g., IEC 60601-1, ISO 10993) related to electrical safety, electromagnetic compatibility, usability, and biocompatibility.
The conclusion is based on comparing the subject device to the predicate device in terms of design, intended use, indications for use, functions, materials, and applicable standards, as well as adherence to these safety and performance standards. It explicitly states: "The subject device is as safe, as effective, and performs as well as the legally marketed predicated devices K172662." This implies that by meeting the same safety and performance benchmarks as the predicate, and having similar characteristics and indications for use, it is considered "effective" in the regulatory sense for substantial equivalence, rather than through a dedicated clinical performance study with specific acceptance criteria.
Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance or details about a study proving the device meets effectiveness criteria, as this information is not present in the provided text. The document is primarily a regulatory submission demonstrating substantial equivalence through technical and safety standards, not a clinical performance study report.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.