510(k) K151816
K151816 is an FDA 510(k) premarket notification submitted by Theralase, Inc. for the device "TLC-2000 Therapeutic Medical Laser System". The FDA issued a decision of Substantially Equivalent on November 19, 2015. 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. Theralase, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 19, 2015
- Date Received
- July 6, 2015
- 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
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.