510(k) K032216
K032216 is an FDA 510(k) premarket notification submitted by Bioptron AG for the device "BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on Feb 4, 2004. The device falls under product code NHN (Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy), a Class II device regulated under 21 CFR 890.5500.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 4, 2004
- Date Received
- Jul 21, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
- Device Class
- Class II
- Regulation Number
- 890.5500
- Review Panel
- PM
- Submission Type
- 510(k)
A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. This device emits energy in the infrared or other wavelengths, provides non-heating and non-thermal effect, and is indicated for adjunctive use in pain therapy or related indication. It does not provide therapeutic topical heating. The classification regulation for infrared lamps describes a device that emits energy in the infrared wavelength to provide topical heating and that is not limited to adjunctive use.