Cleared Traditional

PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60

K061024 · Peregrine Surgical , Ltd. · Ophthalmic
Jun 2006
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K061024 is an FDA 510(k) clearance for the PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Peregrine Surgical , Ltd. (New Britain, US). The FDA issued a Cleared decision on June 21, 2006, 69 days after receiving the submission on April 13, 2006. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K061024 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 2006
Decision Date June 21, 2006
Days to Decision 69 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQF — Laser, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4390