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510(k) K031391

HF MODULE WITH TRANSDUCERS by Ophthalmic Technologies, Inc. — Product Code IYO

K031391 is an FDA 510(k) premarket notification submitted by Ophthalmic Technologies, Inc. for the device "HF MODULE WITH TRANSDUCERS". The FDA issued a decision of Substantially Equivalent on June 20, 2003. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Ophthalmic Technologies, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2003
Date Received
May 2, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

Other clearances by Ophthalmic Technologies, Inc.

  • K042885 — OCT-OPTHALMOSCOPE (January 21, 2005)
  • 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)
  • K971679 — I-SCOPE OPHTHALMIC ENDOSCOPE (June 25, 1997)
  • K960622 — I-SCAN (May 13, 1996)
  • K954263 — XE-LITE (October 18, 1995)

Other clearances for product code IYO

  • K260190 — ARTHUR (June 18, 2026)
  • K252237 — EdgeFlow UW20 (April 17, 2026)
  • K254021 — Accuro XV (April 9, 2026)
  • K253898 — QT Scanner 2000 Model A (March 4, 2026)
  • K253714 — IntraSight Plus (February 24, 2026)
  • K253221 — Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) (February 6, 2026)
  • K250331 — Astrasono A3Pro Bladder Scanner (A3Pro) (September 30, 2025)
  • K250381 — Deepsight NeedleVue LC1 Ultrasound System (August 1, 2025)
  • K243227 — B-Scan (July 11, 2025)
  • K251728 — Velacur One (LI-1100) (June 26, 2025)

FDA data resources