(90 days)
The VIKINI DIODE LASER SYSTEM is indicated for hair removal, permanent hair reduction and for the treatment of benign vascular and pigmented lesions.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Not Found
The provided document, a 510(k) premarket notification letter for the VIKINI DIODE LASER SYSTEM, does not contain details about specific acceptance criteria or an internal study demonstrating how the device meets those criteria.
This document is an FDA clearance letter, which means the FDA has determined that the VIKINI DIODE LASER SYSTEM is substantially equivalent to legally marketed predicate devices. This determination is based on the information provided by the manufacturer in their 510(k) submission, which would have included data to support the device's safety and effectiveness. However, the clearance letter itself does not typically detail the specific studies performed or the acceptance criteria used within those studies.
To answer your request, one would typically need to review the actual 510(k) submission document (which is not provided here) that ILOODA Company, Ltd. submitted to the FDA for the VIKINI DIODE LASER SYSTEM. This submission would contain the detailed studies, acceptance criteria, and performance data.
Based solely on the provided text, I can only state the 'Indications for Use', which serve as the broad performance goals for the device:
- Hair removal
- Permanent hair reduction (defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen)
- Treatment of benign vascular lesions
- Treatment of pigmented lesions
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
- If a standalone performance test was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
In summary, the provided document is a regulatory clearance letter, not the technical study report itself.
§ 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.