(166 days)
- At the 1064 nm wavelength dark ink tattoo removal, removal of pigmented lesions . and the removal or lightening of hair.
- At the 532 nm wavelength removal of red ink tattoos, treatment of vascular lesions including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigines, ephildes)
The UltraLight II Nd: Y AG Laser System consists of a power supply unit with cooling, a footswitch and an umbilical cord that connects to the laser, which is located in the handpiece. In standard use, the handpiece is held against the treatment area dn the light pulse is delivered when the footswitch is depressed. Laser parameters and other system features are controlled from the display panel located on the front of the power supply unit.
The provided text describes the UltraLight II Nd:YAG Laser System, but it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
The document is a 510(k) Summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against specific acceptance criteria. The "Performance Data: Results of Clinical Study:" section explicitly states "None," indicating that no clinical study was performed or submitted to support this 510(k) submission.
Therefore, I cannot provide the requested information, and the following table and details will be left blank or indicated as "Not provided in the input."
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the input | Not provided in the input |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not provided in the input (no test set mentioned).
- Data Provenance: Not provided in the input (no test set mentioned).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not provided in the input (no test set mentioned).
- Qualifications of Experts: Not provided in the input (no test set mentioned).
4. Adjudication method for the test set:
- Adjudication Method: Not provided in the input (no test set mentioned).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No.
- Effect Size: Not applicable (no MRMC study mentioned, and the device is a laser system, not an AI assistance tool for human readers).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance Study: No. The device is a laser system, not an algorithm.
7. The type of ground truth used:
- Type of Ground Truth: Not applicable (no performance study was conducted or presented in this document).
8. The sample size for the training set:
- Sample Size: Not applicable (no training set mentioned, as no performance study was conducted or presented).
9. How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable (no training set mentioned).
§ 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.