(27 days)
The Aurora DS is intended for use in dermatology for non invasive hair removal.
The Aurora DS is indicated for non-invasive hair removal.
The Aurora DS is a device that is used for non-invasive hair removal. The Aurora DS treatment is based on a principle of selective thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen (and optimized) to selectively damage (destroy) hair and follicle without damaging the surrounding tissues.
I'm sorry, but this document does not contain the information you requested about acceptance criteria and a study proving device performance. The provided text is a 510(k) summary for a medical device (Aurora DS) and a clearance letter from the FDA. It primarily focuses on the device description, its intended use, modifications from a predicate device, and the FDA's determination of substantial equivalence for market clearance.
Here's a breakdown of what is and is not in the document:
What is present:
- Device Name: Aurora DS
- Intended Use: Non-invasive hair removal.
- Predicate Device: Aurora DS cleared under K031988 (this is a Special 510(k) for modifications).
- Device Description: A device used for non-invasive hair removal based on selective thermolysis using optical and RF energy.
- Modification: An increase in light energy output.
- FDA Clearance: The device was cleared under K033586.
What is not present (and what you requested):
- A table of acceptance criteria and reported device performance.
- Details about sample size for test sets or training sets.
- Data provenance (country of origin, retrospective/prospective).
- Number/qualifications of experts for ground truth.
- Adjudication method.
- Information on MRMC comparative effectiveness studies or human reader improvement.
- Information on standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- How ground truth for training or test sets was established.
The document states that "The modifications to the Aurora DS do not affect the intended use or alter the fundamental scientific technology of the device... The device modifications raise no new issues of safety or effectiveness." This implies that the previous clearance for the predicate device would have established the fundamental safety and effectiveness, and the current submission is arguing that the changes do not change that. However, the details of those studies are not in this document.
§ 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.