510(k) K873330
K873330 is an FDA 510(k) premarket notification submitted by Laserscope for the device "KTP/532 LASER". The FDA issued a decision of Substantially Equivalent on November 18, 1987. The device falls under product code LNK (Laser For Gastro-Urology Use), a Class II device regulated under 21 CFR 878.4810. Laserscope has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 18, 1987
- Date Received
- August 19, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser For Gastro-Urology Use
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- GU
- Submission Type