(185 days)
The Omnilux New-U is intended to emit energy in the red and IR region of the spectrum, specifically indicated to reduce periorbital wrinkles.
The Omnilux New-U is intended to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
The Omnilux New-U is a source of high spectral purity. It provides uniform or "hot-spot" free illumination. The outputs are pre-tuned to a particular wavelength with a narrow spectral bandwidth. The red output of the Omnilux New-U is 633 + 6 nm, and the IR output is 830 ± 5 nm. The Omnilux New-U device itself contains a selector switch (red/off/IR), the LED array assembly, and arrangements for air cooling. A separate, universal, power supply converts mains AC power to the DC power required by the Omnilux New-U. Treatment time is controlled by the operator.
The provided document describes the Omnilux New-U, a device intended to reduce periorbital wrinkles. However, it does not include detailed acceptance criteria or a specific study proving the device meets said criteria.
Instead, the submission relies on the assertion that its performance characteristics are not significantly different from previously approved predicate devices (Omnilux Revive, Omnilux plus, Omnilux revive/Omnilux plus combination). The FDA's 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical efficacy trials for every new submission, especially for a device with a similar mechanism of action and intended use.
Therefore, many of the requested details about acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not present in this 510(k) summary.
Here's a breakdown of what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of quantitative clinical criteria. The filing relies on substantial equivalence. | Asserted substantial equivalence to predicate devices: "Photo Therapeutics Limited believes that no significant differences exist between the previously approved Omnilux revive (K030426), Omnilux plus (K043317), Omnilux revive/Omnilux plus combination (K050216) and the Omnilux New-U. Therefore, the Omnilux New-U raises no new issues of safety or effectiveness." |
| Indication for Use: Reduce periorbital wrinkles. | The device is intended to emit energy in the red and IR region of the spectrum, specifically indicated to reduce periorbital wrinkles. |
| Red output wavelength/bandwidth | 633 ± 6 nm |
| IR output wavelength/bandwidth | 830 ± 5 nm |
| Uniform illumination (no "hot-spots") | Provides uniform or "hot-spot" free illumination. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. The document does not describe a new clinical study to establish efficacy for the Omnilux New-U itself. Its clearance is based on substantial equivalence to predicate devices, for which clinical data would have been submitted in their respective 510(k)s.
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 / Not provided. Since no new clinical study data for the Omnilux New-U is presented, there is no mention of experts establishing ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided.
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 / Not provided. This device is for direct therapeutic application, not an AI diagnostic tool involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not provided. This is a hardware device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided for the Omnilux New-U. For the predicate devices, it would likely have involved clinical assessment of wrinkle reduction (e.g., photographic analysis by experts, patient self-assessment, or validated wrinkle scales).
8. The sample size for the training set:
- Not applicable / Not provided. No new clinical study data (and thus no training set) for the Omnilux New-U is presented.
9. How the ground truth for the training set was established:
- Not applicable / Not provided.
Summary of the Study (or lack thereof) provided:
The submission for the Omnilux New-U relies entirely on the concept of substantial equivalence to predicate devices (Omnilux Revive, Omnilux plus, Omnilux revive/Omnilux plus combination). The manufacturer, Photo Therapeutics Limited, asserts that "no significant differences exist" between the Omnilux New-U and these previously cleared devices in terms of "overall performance characteristics." Therefore, they argue the Omnilux New-U "raises no new issues of safety or effectiveness."
The FDA's clearance (K072459) of the Omnilux New-U indicates that they agreed with this assessment of substantial equivalence, allowing the device to be marketed. This is a common pathway for medical device clearance in the US, especially when new devices are similar in technology and intended use to existing ones. It means specific new clinical studies to prove efficacy were not required for this particular 510(k) submission.
§ 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.