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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:

1. 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.
2. 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.
3. 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.
4. Adjudication method for the test set: Not applicable.
5. 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.
6. Stand-alone (algorithm only without human-in-the-loop performance): Not applicable. This is a light-based treatment device, not an AI algorithm.
7. 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.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device that requires a training set.
9. 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.

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