Manufacturer
Uvbiotek, LLCPhotodynamic Therapy Device
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K170187
- Device name
- Photodynamic Therapy Device
- Company
- Uvbiotek, LLC
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2017-01-23
- Decision date
- 2017-07-28
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Acne treatment
- Primary application
- Acne treatment
- Classification source
- AI classified
Indications for Use
The Photodynamic Therapy Device combination of Red (633nm±10nm) and Blue (417nm±10nm) is intended to emit energy in the red, blue regions of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
Intended Use
The Photodynamic Therapy Device combination of Red (633nm±10nm) and Blue (417nm±10nm) is intended to emit energy in the red, blue regions of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
Device Description
The Photodynamic Therapy Device KN-7000A is a portable device which uses specific wavelengths of light, produced by light emitting diodes (LEDs), to manage aesthetic conditions. The device produces light in the red light region of the light spectrum (633±10nm) and/or in the blue light region of the light spectrum (417±10nm), intended to help reduce the appearance of mild to moderate acne. There are three irradiators available, Blue LED, Red LED and Blue/Red LED. This device is mainly made up of the main frame, the irradiator, and the lifting stand. After installing the KN-7000A Photodynamic Therapy Device, the phototherapy patient should be instructed to remove cosmetics, wash their face with water and wipe it dry before therapy. The special protective eyewear should be used to cover both eyes to prevent possible injury by the irradiator. Set treatment parameters on the main interface of the screen, operate the irradiator and make sure that the correct operating distance (6cm±1cm) from the patient's treatment area. When using pure red, pure blue treatment head alternate irradiation, pure red LEDs irradiates 15 minutes per treatment, pure blue LEDs irradiates 13 minutes per treatment, twice weekly, 8 times per course of treatment; When using red and blue combination treatment head alternate irradiation, red LEDs irradiates 30 minutes per treatment, blue LEDs irradiates 22 minutes per treatment, twice weekly, 8 times per course of treatment.
Summary parsed at:2026-06-01 05:59:33 UTC
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Cited as predicate
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