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510(k) K202670

Nam illumination probe with chopper by Oculight , Ltd. — Product Code MPA

K202670 is an FDA 510(k) premarket notification submitted by Oculight , Ltd. for the device "Nam illumination probe with chopper". The FDA issued a decision of Substantially Equivalent on August 20, 2021. 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 20, 2021
Date Received
September 14, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K151604 — 23ga Chandelier Illuminator, 25ga Chandelier Illuminator (September 11, 2015)
  • K143123 — Synergetics PHOTON EX (February 24, 2015)
  • K080067 — ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER (July 18, 2008)
  • K062895 — XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII (October 13, 2006)
  • K062259 — ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100 (August 15, 2006)
  • K041108 — ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA (June 22, 2004)
  • K032598 — SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE (November 24, 2003)

FDA data resources