(176 days)
Intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. Indicated as an over-the-counter phototherapy device for the treatment of mild to moderate acne.
The dpl® Nüve is a lightweight, handheld, light emitting diode (LED) device with interchangeable heads which emit light energy. A blue LED head in the 415 nm spectrum is used in treatment for mild to moderate inflammatory acne. A red head at 625 nm and a purple head (infrared) in the 830 nm spectrum are used in combination for reduction of periorbital wrinkles. The handle of the device contains the electronics of the device including a fan for cooling and an automatic shut-off safety feature
The provided text does not contain information about acceptance criteria for the device's performance in treating periorbital wrinkles or acne, nor does it detail a study proving the device meets specific performance criteria.
Instead, the document focuses on:
- Substantial Equivalence: The primary assertion is that the
dpl® Nüveis "substantially equivalent in function and technology" to predicate devices (Omnilux New U for wrinkles and Tanda Skin Care for acne). This means the device is considered as safe and effective as existing legally marketed devices, rather than meeting specific quantifiable performance benchmarks detailed in the submission. - Safety Testing: The device's safety is demonstrated by meeting general electrical safety standards (IEC 60601-1, EN 60601-1-2, EN 60601-2-22) and patient contact material safety (ISO 10993).
- Intended Use/Indications for Use: These describe the therapeutic areas the device is cleared for (periorbital wrinkles and mild to moderate acne).
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and performance study details based on the provided text. The document does not describe a clinical study with quantifiable performance metrics, sample sizes, expert ground truth, or an MRMC study.
§ 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.