(324 days)
The Pro X OTC 5 is an Over-The-Counter device intended for use in the treatment of facial wrinkles. It is for people with wrinkles on their face and who have Fitzpatrick skin types I, II and/or III.
The Pro X OTC 5 is an Over-the-Counter device intended for use in the treatment of facial wrinkles. Facial wrinkles are lines on the skin that appear as you age. Facial wrinkles can appear anywhere on the face, such as on the forehead, around the eyes, and by the mouth. The Pro X OTC 5 is for people with wrinkles on their face and who have Fitzpatrick skin types I, II, and/or III.
The Pro X OTC 5 uses known LED light therapy technology. A combination of red light (620-630mm) and infrared light (855nm) is emitted. To use the Pro X OTC 5 device, users place the lightweight mask over the face and then press the "On" button on the controller to start treatment. The device will automatically turn off after each treatment cycle.
The Pro X OTC 5 device is designed to be used for 30 treatment sessions. The full treatment regimen for facial wrinkles includes 60 individual treatments, therefore purchase of two (2) devices is needed to receive the full treatment regimen.
Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:
Device Name: Pro X OTC 5 Light Therapy Device
Intended Use: Treatment of facial wrinkles in people with Fitzpatrick skin types I, II, and/or III.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined "acceptance criteria" with numerical thresholds for clinical performance. Instead, it aims to demonstrate substantial equivalence to predicate devices and effectiveness through a clinical study. The primary measure of effectiveness is improvement in Fitzpatrick Wrinkle and Elastosis Scale scores.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Clinical Effectiveness: | |
| Improvement in facial wrinkles (as measured by Fitzpatrick Wrinkle and Elastosis Scale). | Treatment Group (n=30): |
| Physician 1: | |
| - Baseline mean grade: 5.10 | |
| - 8-week mean grade: 3.86 (1.24 point improvement) | |
| - 20-week post-treatment mean grade: 3.83 (1.28 point improvement from baseline) | |
| Physician 2: | |
| - Baseline mean grade: 5.03 | |
| - 8-week mean grade: 3.83 (1.21 point improvement) | |
| - 20-week post-treatment mean grade: 3.90 (1.14 point improvement from baseline) | |
| Individual Improvement: Each subject in the treatment group demonstrated at least 1 point improvement (baseline vs. 20-weeks post-treatment). | |
| Statistical Significance: Treatment Group showed statistically significant improvement (p |
§ 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.