(84 days)
LaserCap300, LaserCap224, LaserCap120, and LaserCap80 are intended for the promotion of hair growth in females with androgenetic alopeda who have Ludwig-Savin Classifications of 1 - 11 and males with androgenetic alopecia who have Hamilton-Norwood Classifications of lla-V and for both, Fitzpatrick Skin Phototypes I to IV.
LaserCap300, LaserCap224, LaserCap120, and LaserCap80 consist of red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner liner, and configured for portable use with rechargeable battery and adapter. The devices only vary in number of lasers (300, 224, 120, and 80 diodes, respectively) and LaserCap300 has a small extension of the LaserCap housing perimeter where its additional laser diodes target peripheral hair-bearing areas of the scalp. As stated in prior submissions, the devices emit an audible tone at the beginning and end of a therapy session, indicating that therapy has begun (1 short beep) or ended (one long beep). The portable systems are powered by rechargeable Li-lon battery cells assembled into a proprietary battery pack. Both the battery pack and charger are fully compliant to recognized, international standards.
The provided text describes the regulatory filing for the "LaserCap" family of devices (LaserCap300, LaserCap224, LaserCap120, LaserCap80) for promoting hair growth. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone clinical study to prove new acceptance criteria.
Therefore, the information you requested about acceptance criteria met by a specific study is not directly available in the provided text as the application relies on proving similarity to already approved devices.
However, I can extract information related to the device's performance based on the substantial equivalence argument, which implies that the device meets the same safety and effectiveness standards as the predicate devices.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating sameness to predicate devices that have already met regulatory standards. The reported device performance is therefore described in terms of its technological characteristics matching, or being acceptably similar to, predicate devices.
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (LaserCap Family) |
|---|---|
| Safety: | |
| Laser Classification (e.g., 3R) | Conforms to IEC 60825-1, Class 3R |
| Accessible Emission Limits (AEL) |
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.