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510(k) K830871

PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION by Phakosystems, Inc. — Product Code HOC

K830871 is an FDA 510(k) premarket notification submitted by Phakosystems, Inc. for the device "PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION". The FDA issued a decision of Substantially Equivalent on June 2, 1983. The device falls under product code HOC (Clip, Iris Retractor), a Class I device regulated under 21 CFR 886.4350. Phakosystems, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1983
Date Received
March 18, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Iris Retractor
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances by Phakosystems, Inc.

  • K880081 — VISION CARE/PHAKOSYSTEMS ECHOPACH (March 15, 1988)
  • K871938 — VISION CARE/PHAKOSYSTEMS ECHORULE (November 23, 1987)
  • K860236 — PHAKOSYSTEMS CT-100 CAUTERY MODULE (February 19, 1986)
  • K851674 — PHAKOSYSTEMS MODEL CES 4100 (August 5, 1985)

Other clearances for product code HOC

  • K871474 — PART #860070 ULTRAPAK & #860075 ULTRAPAK (August 10, 1987)

FDA data resources