510(k) K070776

SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR by Quantel Medical — Product Code HQF

K070776 is an FDA 510(k) premarket notification submitted by Quantel Medical for the device "SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR". The FDA issued a decision of Substantially Equivalent on April 24, 2007. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Quantel Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2007
Date Received
March 21, 2007
Clearance Type
Special
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