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The Revian Lyte device is indicated to treat Androgenetic Alopecia and to promote hair growth in males who have Norwood-Hamilton Classifications of Ila - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale |-1 to |-4, || -1, ||-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

The Revian Lyte device is a model (10011) within the Revian Red (10001) family of devices.

Revian Lyte is an over the counter (OTC) home-use, non-invasive, hands-free device indicated to treat androgenetic alopecia in both men and promote hair growth using Modulated Light Therapy (MLT) and a 10-minute daily treatment. The Revian Lyte cap is designed to treat the scalp and temple areas. The device is a non-sterile, single user, multi-use therapy device.

Revian Lyte is a system comprised of a wearable soft textile cap and protective inner liner together which encase driver electronics, a rechargeable battery, and an integrated light emitting diode (LED) array on a flexible Printed Circuit Board (PCB). The protective inner liner, a plastic lenticular lens, covers the treatment LED array and electronics and is in direct contact with the patient's scalp. The lenticular lens disperses LED light over the treatment area. The Revian Lyte device emits non-coherent visible red light at two target peak wavelengths (620nm and 660nm).

When the Lyte cap is placed onto the head, a capacitive touch sensor (proximity sensor) embedded in the flexible printed circuit board senses the presence of the scalp and turns on the cap. Removable and adjustable foam headliners ensure that the cap fits snugly on the scalp and ensure that the proximity sensor is in close contact with the scalp. A series of blinking indicator LEDs and audible tones provide information to the user such as the status of battery charge, treatment status, etc. At the end of treatment, a series of 3 audible beeps signal that the treatment has finished and the device automatically shuts off. Lyte is controlled via embedded firmware.

The battery is recharged between uses using an AC power adapter and a USB charging cable.

The Revian Lyte includes:

(1) A treatment cap with integrated electronics,

(2) Accessory Kit containing the USB Charging Cable with AC Power Adaptor and set of Adjustable Headliners,

(3) Clear Charging Base used to rest the Cap when not in use and to rest the Cap to charge between treatments and,

(4) Instructions for Use (IFU).

This document is a 510(k) premarket notification for the Revian Lyte device, which is a low-level light therapy (LLLT) device intended to treat androgenetic alopecia and promote hair growth. The information provided focuses on demonstrating substantial equivalence to a predicate device (Revian Red, K173729) and a reference device (iHelmet, K190467).

Based on the provided text, there is no acceptance criteria table or a study proving the device meets specific performance criteria through clinical data. The document explicitly states:

"10. Clinical Test Summary: No clinical information is included in this submission."

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample size used for the test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth type, training set sample size, or how ground truth was established for a clinical study.

The submission focuses entirely on non-clinical tests to demonstrate safety and performance equivalence to the predicate device, primarily through bench testing, compliance with IEC standards, firmware verification/validation, cybersecurity assessment (stating no external interfaces), and usability testing for the modified user interface.

Here's a breakdown of the non-clinical testing performed, which is what the document does provide:

Non-Clinical Test Summary:

• Safety:
  • Evaluated and bench tested for optical safety, passed (equivalent to Revian Red per IEC 62471).
  • Evaluated by an NRTL lab to IEC 60601-2-57 and is compliant.
  • Tested and evaluated for compliance to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-1-11 and is compliant.
• Performance:
  • Tested for optical performance and electrical characteristics and passed all requirements.
• Firmware Verification/Validation:
  • Modifications due to removal of mobile application were verified/validated via firmware validation.
• Cybersecurity:
  • The device has no external interfaces, according to FDA guidance.
• Usability:
  • Modifications to the instructions for use and user interface (due to removal of mobile app) were verified/validated via usability/human factors testing.
• Biocompatibility:
  • No changes to tissue-contacting materials, thus no biocompatibility testing was performed.

Summary of what is NOT provided by the document regarding the requested clinical study information:

• 1. A table of acceptance criteria and the reported device performance: Not provided for clinical performance as no clinical data was submitted.
• 2. Sample sized used for the test set and the data provenance: Not applicable as no clinical test set was used.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method for the test set: Not applicable.
• 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 an LLLT device, not an AI-assisted diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not a diagnostic algorithm.
• 7. The type of ground truth used: Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

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