ClearLink Controlled Phototherapy Equipment
by Daavlin Distributing Company 510(k)
Active
510(k) K182215
Overview
The ClearLink Controlled Phototherapy Equipment is a light, ultraviolet, dermatological device classified as Class II under FDA regulation number 878.4630. It is substantially equivalent to a predicate device and was cleared via the traditional 510(k) pathway under K182215.
The device is manufactured by Daavlin Distributing Company and is intended for use in dermatologic disorders. It is supplied as a non-sterile, reusable system for controlled phototherapy treatment in clinical or home settings, with no MRI safety information provided in the data.
Regulatory status
Recall ongoing. 1 ongoing FDA recall. See recalls
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK182215 | Date29 Oct 2018 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Ongoing Z-2744-2026
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
Specification
- 510(k) Number
- FDA Product Code
- FTC
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4630
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
From the manufacturer
Daavlin offers a complete line of phototherapy units designed to be used in the comfort, privacy, and convenience of your own home. Choose to be in control of your skin—don't let your skin control you!
Note: Only Daavlin's 1 Series or 4 Series devices, when equipped with blue lamps and controlled with the ClearLink Controlled Phototherapy Equipment, have intended use for the treatment of acne vulgaris.
Other devices from Daavlin Distributing Co.
Questions
What is the ClearLink Controlled Phototherapy Equipment used for?
The ClearLink Controlled Phototherapy Equipment is intended for use in dermatologic disorders as a light, ultraviolet, dermatological device for controlled phototherapy treatment in clinical or home settings.
Is the ClearLink Controlled Phototherapy Equipment sterile or non-sterile, and is it reusable?
The device is supplied as a non-sterile, reusable system, meaning it is not provided in a sterile condition and is designed for multiple uses after appropriate cleaning and maintenance.
How was the ClearLink Controlled Phototherapy Equipment cleared for market?
The device was cleared via the traditional 510(k) pathway under K182215, demonstrating substantial equivalence to a predicate device under FDA regulation number 878.4630.