510(k) K141564
K141564 is an FDA 510(k) premarket notification submitted by Zimmer Medizinsystems GmbH for the device "OPTON PRO". The FDA issued a decision of Substantially Equivalent on October 24, 2014. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Zimmer Medizinsystems GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 24, 2014
- Date Received
- June 12, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Lamp, Infrared, Therapeutic Heating
- Device Class
- Class II
- Regulation Number
- 890.5500
- Review Panel
- PM
- Submission Type