Cleared Traditional

K990064 - DI-RHEX OPHTHALMIC DIATHERMY SYSTEM
(FDA 510(k) Clearance)

K990064 · Ophthalmic Technologies, Inc. · Ophthalmic

Apr 1999

Decision

86d

Days

Class 2

Risk

K990064 is an FDA 510(k) clearance for the DI-RHEX OPHTHALMIC DIATHERMY SYSTEM, a Apparatus, Cautery, Radiofrequency, Ac-powered (Class II — Special Controls, product code HQR), submitted by Ophthalmic Technologies, Inc. (Downsview, Ontario, CA). The FDA issued a Cleared decision on April 4, 1999, 86 days after receiving the submission on January 8, 1999. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4100.

Submission Details

510(k) Number	K990064 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 08, 1999
Decision Date	April 04, 1999
Days to Decision	86 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF