(364 days)
The LYMA Laser is an Over the-Counter (OTC) light based device intended for the use in treating full-face wrinkles.
The LYMA Laser is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles. The LYMA Laser incorporates a near-infrared LED light source within the optimum Therapeutic Optical Window at 808 nm, optimized for Low Level Light Therapy, and a red LED light source at 620 nm. An optical lens that diffuses the light to produce narrowband, divergent distribution across an 8 cm² treatment area. The energy output of the 808 nm and 620 nm wavelengths is 62.5 mW/cm² which produces a beneficial treatment for full-face wrinkles.
The provided FDA 510(k) summary for the LYMA Laser focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance criteria through a clinical study with acceptance criteria.
The submission primarily relies on:
- Comparison of technological characteristics: Showing the LYMA Laser has similar output, wavelengths, treatment duration, and treatment area as previously cleared devices.
- Non-clinical testing: Ensuring the device meets electrical safety, electromagnetic compatibility, laser safety, and biocompatibility standards.
- Usability testing: Demonstrating that lay users can understand the labeling and safely operate the device.
Therefore, the document does not contain the information requested regarding a study that proves the device meets specific acceptance criteria for its intended clinical effect (treating full-face wrinkles). The FDA cleared this device based on its similarity to existing, legally marketed devices, not on new clinical efficacy data demonstrating wrinkle reduction performance against pre-defined acceptance criteria.
Here's why the specific questions cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present because a clinical efficacy study with such criteria was not provided or required for the 510(k) clearance based on substantial equivalence.
- Sample size used for the test set and data provenance: No clinical test set data for efficacy is provided. The usability study mentions 26 participants for two parts, but this is for user comprehension and operation, not clinical performance.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable as no clinical efficacy test set with ground truth was presented.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study (often for AI in imaging) was not performed or needed for this device.
- Stand-alone (algorithm only without human-in-the-loop performance): Not applicable. This is a light-based treatment device, not an AI algorithm.
- The type of ground truth used: Not applicable for clinical efficacy. The "ground truth" for the usability study was whether participants could correctly self-select and operate the device.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document details a 510(k) submission based on substantial equivalence, non-clinical safety testing, and usability testing, not a clinical efficacy study with pre-defined acceptance criteria for wrinkle reduction.
§ 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.