510(k) K924844

BULK TISSUE REMOVAL SYSTEM by L.A.S.E.R., Inc. — Product Code HET

K924844 is an FDA 510(k) premarket notification submitted by L.A.S.E.R., Inc. for the device "BULK TISSUE REMOVAL SYSTEM". The FDA issued a decision of Substantially Equivalent on October 8, 1993. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. L.A.S.E.R., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 1993
Date Received
September 28, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type