Frag Commander

FDA 510(k) K973749 · Scieran Technologies, Inc.

Substantially Equivalent

510(k) numberK973749

Submission

Device name
Frag Commander
Applicant
Scieran Technologies, Inc.
Laguna Hills, CA, US
Received
October 1, 1997
Decision date
December 8, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HQC – Unit, Phacofragmentation
Device class
Class II (moderate risk)
Regulation
21 CFR 886.4670
Specialty
Ophthalmic

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More from Alcon Laboratories, Inc.

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K974253CPD CommanderMRH · Traditional 02/25/1998SE
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Questions and answers

When was Frag Commander cleared by the FDA?

Frag Commander (K973749) received a 510(k) decision of Substantially Equivalent on December 8, 1997, 68 days after the submission was received.

What is the product code of K973749?

The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.