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510(k) K062259

ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100 by Iscience Surgical — Product Code MPA

K062259 is an FDA 510(k) premarket notification submitted by Iscience Surgical for the device "ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100". The FDA issued a decision of Substantially Equivalent on August 15, 2006. The device falls under product code MPA (Endoilluminator), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2006
Date Received
August 4, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Endoilluminator
Device Class
Class II
Regulation Number
876.1500
Review Panel
OP
Submission Type

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  • K062895 — XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII (October 13, 2006)
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FDA data resources