Acufocus Inc

FDA Filings

This page includes the latest FDA filings for Acufocus Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3008401069
• FEI Number: 3008401069
• Name: ACUFOCUS, INC.
• Owner & Operator: AcuFocus, Inc.
• Contact Address: 32 Discovery Suite 200; Irvine CA 92618 US
• Official Correspondent:
  • Sandra Selvaggi
  • x-949-2710293-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 32 Discovery Suite 200; Irvine, CA 92618 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 00813359021134 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-300	2023-01-12
GUDID 00813359021127 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-295	2023-01-12
GUDID 00813359021110 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-290	2023-01-12
GUDID 00813359021103 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-285	2023-01-12
GUDID 00813359021097 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-280	2023-01-12
GUDID 00813359021080 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-275	2023-01-12
GUDID 00813359021073 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-270	2023-01-12
GUDID 00813359021066 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-265	2023-01-12
GUDID 00813359021059 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-260	2023-01-12
GUDID 00813359021042 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-255	2023-01-12
GUDID 00813359021035 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-250	2023-01-12
GUDID 00813359021028 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-245	2023-01-12
GUDID 00813359021011 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-240	2023-01-12
GUDID 00813359021004 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-235	2023-01-12
GUDID 00813359020991 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-230	2023-01-12
GUDID 00813359020984 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-225	2023-01-12
GUDID 00813359020977 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-220	2023-01-12
GUDID 00813359020960 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-215	2023-01-12
GUDID 00813359020953 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-210	2023-01-12
GUDID 00813359020946 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-205	2023-01-12
GUDID 00813359020939 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-200	2023-01-12
GUDID 00813359020922 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-195	2023-01-12
GUDID 00813359020915 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-190	2023-01-12
GUDID 00813359020908 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-185	2023-01-12
GUDID 00813359020892 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-180	2023-01-12
GUDID 00813359020885 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-175	2023-01-12
GUDID 00813359020878 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-170	2023-01-12
GUDID 00813359020861 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-165	2023-01-12
GUDID 00813359020854 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-160	2023-01-12
GUDID 00813359020847 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-155	2023-01-12
GUDID 00813359020830 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-150	2023-01-12
GUDID 00813359020823 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-145	2023-01-12
GUDID 00813359020816 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-140	2023-01-12
GUDID 00813359020809 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-135	2023-01-12
GUDID 00813359020793 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-130	2023-01-12
GUDID 00813359020786 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-125	2023-01-12
GUDID 00813359020779 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-120	2023-01-12
GUDID 00813359020762 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-115	2023-01-12
GUDID 00813359020755 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-110	2023-01-12
GUDID 00813359020748 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-105	2023-01-12
GUDID 00813359020731 ACUFOCUS, INC.	IC-8 Apthera IOL 82078-100	2023-01-12
GUDID 00813359020052 ACUFOCUS, INC.	KAMRA inlay	2018-03-29
GUDID 00813359020045 ACUFOCUS, INC.	KAMRA inlay	2018-03-29
GUDID 00813359020007 ACUFOCUS, INC.	KAMRA inlay	2018-03-29
PMN P120023 | LQE ACUFOCUS, INC.	KAMRA? inlay	2015-04-21

Similar & Related FDA Registered Companies

• AcuFocus, Inc.32 Discoverysuite 200irvine, CA 92618 PMA NumberP210005 Supplement NumberS004 Date Received11/04/2022 Decision Date12/02/2022 Product Code POE  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• AcuFocus, Inc.32 Discoverysuite 200irvine, CA 92618 PMA NumberP210005 Supplement NumberS001 Date Received08/23/2022 Decision Date09/20/2022 Product Code POE  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• AcuFocus, Inc.32 Discoverysuite 200irvine, CA 92618 PMA NumberP210005 Supplement NumberS002 Date Received08/23/2022 Decision Date09/20/2022 Product Code POE  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• AcuFocus, Inc.32 Discoverysuite 200irvine, CA 92618 PMA NumberP210005 Date Received02/24/2021 Decision Date07/22/2022 Product Code POE  Advisory Committee Ophthalmic Clinical TrialsNCT03633695 Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	7VKL3	ACUFOCUS, INC.!DBA ACUFOCUS
CAGE Code	7VKL3	ACUFOCUS, INC. ACUFOCUS
SEC	0001165260	AcuFocus, Inc. of DELAWARE