(90 days)
The LightSheer™ is intended to effect hair removal of patients with skin types 1 - 4 through selective targeting of melanin in hair follicles. The LightSheer™ is a prescription device (12 CFR 801.109)
LightSheer™ laser is a long pulse ruby laser which delivers its energy to the treatment site via two quartz fiber optics. The beam exits from a chilled hand piece which is held in firm contact with the skin at the treatment site.
The provided text is a 510(k) summary for the LightSheer™ Long Pulse Ruby Laser. It outlines the device's intended use and claims substantial equivalence to a predicate device, the EpiLaser®. However, it explicitly states "None required" for performance data. This means a study specifically proving the device meets acceptance criteria was not conducted or reported in this submission because the FDA deemed it unnecessary due to the substantial equivalence claim.
Therefore, many of the requested details about acceptance criteria and a detailed study are not available in this document.
Here's what can be extracted based on the provided text, with clarifications where information is missing:
1. A table of acceptance criteria and the reported device performance
Since "Performance Data: None required" is explicitly stated, there are no specific numerical acceptance criteria or reported device performance metrics from a study to present in a table. The basis for clearance is substantial equivalence to the predicate device, not a new performance study.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| No specific acceptance criteria were defined or reported in this 510(k) summary. | No specific performance data was reported as "None required" due to substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable, as no performance data study was conducted or reported.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable, as no performance data study was conducted or reported.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable, as no performance data study was conducted or reported.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a laser for hair removal, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a laser for hair removal, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable, as no performance data study was conducted or reported.
8. The sample size for the training set
- Not applicable, as no performance data study was conducted or reported.
9. How the ground truth for the training set was established
- Not applicable, as no performance data study was conducted or reported.
Summary of Device Acceptance:
The LightSheer™ Long Pulse Ruby Laser was accepted based on a substantial equivalence claim to the legally marketed predicate device, the EpiLaser®. The 510(k) summary argues that "The specifications, performance and intended use of the LightSheer™ are the same or similar as the EpiLaser®" and "The differences between the lasers are not significant in terms of the performance or intended use of the LightSheer™." Therefore, the FDA did not require a new performance study to prove the device meets specific acceptance criteria.
§ 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.