Manufacturer
Ward Photonics, LLCPhotonica Professional
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
- K150336
- Device name
- Photonica Professional
- Company
- Ward Photonics, LLC
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2015-02-10
- Decision date
- 2015-02-24
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Vascular treatmentPigment treatment
- Primary application
- Vascular treatment
- Classification source
- AI classified
Indications for Use
In dermatology for treatment of superficial, benign vascular, and pigmented lesions.
Intended Use
Photonica is intended for use in dermatology for treatment of superficial, benign vascular and pigmented lesions.
Device Description
The Photonica Professional ("Photonica") is a non‐invasive red light system with a power output of 105mW/cm², consisting of 150 light emitting diodes (LEDs) that emit visible light at nominal wavelength of 635nm ± 2nm (visible red light spectrum) and a spectral bandwidth of 10nm. The components include a mobile pole cart, controller console which plugs into a hospital‐grade isolation transformer, LED array mounted on an articulated arm, 20 minute timer, on/off switch, and a hospital‐grade power cable. The articulated arm allows the light fixture to be positioned in a wide variety of positions. Treatment time is preset to 20 minutes via a validated internal timer delay relay. The light fixture is positioned 17cm (6.8") from the patient's skin to deliver the standard dose output intensity of 105mW/cm² and standard energy dose of 126 J/cm². Photonica does not use any software.Summary parsed at:2026-06-01 06:10:54 UTC
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Cited as predicate
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