510(k) K061024

PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60 by Peregrine Surgical , Ltd. — Product Code HQF

K061024 is an FDA 510(k) premarket notification submitted by Peregrine Surgical , Ltd. for the device "PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60". The FDA issued a decision of Substantially Equivalent on June 21, 2006. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Peregrine Surgical , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2006
Date Received
April 13, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ophthalmic
Device Class
Class II
Regulation Number
886.4390
Review Panel
OP
Submission Type