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510(k) K893199

PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR by Allergan Medical Optics — Product Code HNR

K893199 is an FDA 510(k) premarket notification submitted by Allergan Medical Optics for the device "PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR". The FDA issued a decision of Substantially Equivalent on June 16, 1989. The device falls under product code HNR (Forceps, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Allergan Medical Optics has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1989
Date Received
April 26, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Ophthalmic
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances by Allergan Medical Optics

  • K951462 — AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM (June 15, 1995)
  • K941603 — AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE (July 6, 1994)
  • K930320 — AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR (April 7, 1994)
  • K925254 — AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38 (January 7, 1993)
  • K924235 — AMO ELITE (December 23, 1992)
  • K911998 — MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM (July 26, 1991)

Other clearances for product code HNR

  • K022835 — STEPHENS DISPOSABLE FORCEPS (November 1, 2002)
  • K895434 — ALCON FOLDING FORCEPS (December 4, 1989)
  • K891487 — SOFT LENS FOLDING BLOCK (August 15, 1989)
  • K885230 — MCDONALD FOLDING FORCEPS (May 17, 1989)
  • K881049 — BRADBURY INTRAOCULAR RETINAL KIT CAT #200 (September 12, 1988)
  • K883197 — IOL IMPLANTATION FORCEPS (August 22, 1988)
  • K880274 — ADVANCED SURGICAL PRODUCTS SCLERAL PLUG FORCEPS (February 5, 1988)
  • K864266 — OPHTHALMIC KNIFE & FORCEPS (November 28, 1986)
  • K864183 — OPHTHALMIC SURGICAL INSTRUMENTS (November 28, 1986)
  • K864071 — FAULKNER FORCEPS (November 13, 1986)

FDA data resources