510(k) K031828
K031828 is an FDA 510(k) premarket notification submitted by Focus Medical, LLC for the device "NATURALASE LP ND:YAG LASER". The FDA issued a decision of Substantially Equivalent on July 17, 2003. The device falls under product code GEN (Forceps, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Focus Medical, LLC has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 2003
- Date Received
- June 13, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type