Aklarus Phototherapy System
FDA 510(k) K083183 · Hill Laboratories Co.
510(k) numberK083183
Submission
- Device name
- Aklarus Phototherapy System
- Applicant
- Hill Laboratories Co.
Frazer, PA, US - Received
- October 28, 2008
- Decision date
- July 16, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ILY – Lamp, Infrared, Therapeutic Heating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5500
- Specialty
- Physical Medicine
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Questions and answers
When was Aklarus Phototherapy System cleared by the FDA?
Aklarus Phototherapy System (K083183) received a 510(k) decision of Substantially Equivalent on July 16, 2009, 261 days after the submission was received.
What is the product code of K083183?
The FDA product code is ILY – Lamp, Infrared, Therapeutic Heating, a Class II (moderate risk) device regulated under 21 CFR 890.5500.