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510(k) K971679

I-SCOPE OPHTHALMIC ENDOSCOPE by Ophthalmic Technologies, Inc. — Product Code MPA

K971679 is an FDA 510(k) premarket notification submitted by Ophthalmic Technologies, Inc. for the device "I-SCOPE OPHTHALMIC ENDOSCOPE". The FDA issued a decision of Substantially Equivalent on June 25, 1997. The device falls under product code MPA (Endoilluminator), a Class II device regulated under 21 CFR 876.1500. Ophthalmic Technologies, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1997
Date Received
May 7, 1997
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

Other clearances by Ophthalmic Technologies, Inc.

  • K042885 — OCT-OPTHALMOSCOPE (January 21, 2005)
  • K031391 — HF MODULE WITH TRANSDUCERS (June 20, 2003)
  • K030770 — OTI SCAN WITH TRANSDUCERS (March 27, 2003)
  • K024114 — A-SCAN 100 (January 10, 2003)
  • K990064 — DI-RHEX OPHTHALMIC DIATHERMY SYSTEM (April 4, 1999)
  • K974522 — 3D I-SCAN (February 25, 1998)
  • K960622 — I-SCAN (May 13, 1996)
  • K954263 — XE-LITE (October 18, 1995)

Other clearances for product code MPA

  • K242184 — Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (806 (December 4, 2024)
  • K233653 — Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00) (August 5, 2024)
  • K221872 — ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System (March 30, 2023)
  • K202670 — Nam illumination probe with chopper (August 20, 2021)
  • 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)

FDA data resources