Luneau Technology Operations

FDA Filings

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

FDA Registration(s)

• Registration Number: 8020811
• FEI Number: 3000277668
• Name: Joe Vulich
• Owner & Operator: LUNEAU TECHNOLOGY OPERATIONS
• Contact Address: 2 rue Roger Bonnet ; Pont de l'Arche FR-27 Eure 27340 FR
• Official Correspondent:
  • Arianna - Dalla Ba'
  • 33-02-32989132-x
• US Agent:
  • Joe Vulich
  • Luneau Technology USA
  • 630 2746121
  • Joe.Vulich@luneautech.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 224 West James St. ; Bensenville, IL 60106 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

• Registration Number: 3003771740
• FEI Number: 3003771740
• Name: Joe Vulich
• Owner & Operator: LUNEAU TECHNOLOGY OPERATIONS
• Contact Address: 2 rue Roger Bonnet ; Pont de l'Arche FR-27 Eure 27340 FR
• Official Correspondent:
  • Arianna - Dalla Ba'
  • 33-02-32989132-x
• US Agent:
  • Joe Vulich
  • Luneau Technology USA
  • 630 2746121
  • Joe.Vulich@luneautech.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 224 West James St. ; Bensenville, IL 60106 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3009173773
• FEI Number: 3009173773
• Name: LUNEAU TECHNOLOGY OPERATIONS
• Owner & Operator: LUNEAU TECHNOLOGY OPERATIONS
• Contact Address: 2 rue Roger Bonnet ; Pont de l'Arche FR-27 Eure 27340 FR
• Official Correspondent:
  • Arianna - Dalla Ba'
  • 33-02-32989132-x
• US Agent:
  • Joe Vulich
  • Luneau Technology USA
  • 630 2746121
  • Joe.Vulich@luneautech.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2 Rue Roger Bonnet ; PONT DE L ARCHE Eure, 27340 FR
• Establishment Type: Export Device to the United States But Perform No Other Operation on Device

FDA Filings

Device Company	Device	Date
GUDID 03664188000565 LUNEAU TECHNOLOGY OPERATIONS	ESSILOR	2025-01-10
GUDID 03664188000558 LUNEAU TECHNOLOGY OPERATIONS	ESSILOR	2025-01-10
GUDID 03664188000435 LUNEAU TECHNOLOGY OPERATIONS	ESSILOR RET1IN	2025-01-10
GUDID 03664188000312 LUNEAU TECHNOLOGY OPERATIONS	Luneau	2025-01-10
GUDID 03664188000169 LUNEAU TECHNOLOGY OPERATIONS	VISIONIX	2025-01-10
GUDID 03664188000077 LUNEAU TECHNOLOGY OPERATIONS	VISIONIX	2025-01-10
GUDID 03664188000411 LUNEAU TECHNOLOGY OPERATIONS	Visionix	2024-05-08
GUDID 03664188000084 LUNEAU TECHNOLOGY OPERATIONS	Visionix	2023-06-23
GUDID 03664188000930 LUNEAU TECHNOLOGY OPERATIONS	RODENSTOCK	2023-06-16
GUDID 03664188000923 LUNEAU TECHNOLOGY OPERATIONS	RODENSTOCK	2023-06-16
GUDID 03664188000541 LUNEAU TECHNOLOGY OPERATIONS	Visionix	2023-06-16
GUDID 03664188000466 LUNEAU TECHNOLOGY OPERATIONS	Visionix	2023-06-16
GUDID 03664188000459 LUNEAU TECHNOLOGY OPERATIONS	Visionix	2023-06-16
GUDID 03664188000442 LUNEAU TECHNOLOGY OPERATIONS	Visionix	2023-06-16
GUDID 03664188000428 LUNEAU TECHNOLOGY OPERATIONS	Carl Zeiss Meditec	2023-06-16
GUDID 03664188000404 LUNEAU TECHNOLOGY OPERATIONS	Visionix	2023-06-16
GUDID 03664188000398 LUNEAU TECHNOLOGY OPERATIONS	Visionix	2023-06-16
GUDID 03664188000381 LUNEAU TECHNOLOGY OPERATIONS	Visionix	2023-06-16
GUDID 03664188000329 LUNEAU TECHNOLOGY OPERATIONS	Visionix	2023-06-16
GUDID 03664188000251 LUNEAU TECHNOLOGY OPERATIONS	Visionix	2023-06-16
GUDID 03664188000244 LUNEAU TECHNOLOGY OPERATIONS	Visionix	2023-06-16
GUDID 03664188000237 LUNEAU TECHNOLOGY OPERATIONS	Visionix	2023-06-16
GUDID 03664188000220 LUNEAU TECHNOLOGY OPERATIONS	Visionix	2023-06-16
GUDID 03664188000176 LUNEAU TECHNOLOGY OPERATIONS	Visionix	2023-06-16
GUDID 03664188000152 LUNEAU TECHNOLOGY OPERATIONS	Visionix	2023-06-16
GUDID 03664188000145 LUNEAU TECHNOLOGY OPERATIONS	Visionix VX650 10005844	2023-06-16
GUDID 03664188000114 LUNEAU TECHNOLOGY OPERATIONS	Luneau	2023-06-16
GUDID 03664188000091 LUNEAU TECHNOLOGY OPERATIONS	Visionix	2023-06-16
GUDID 03664188000060 LUNEAU TECHNOLOGY OPERATIONS	Visionix	2023-06-16
GUDID 03664188000015 LUNEAU TECHNOLOGY OPERATIONS	Visionix	2023-06-16
GUDID 03664188000008 LUNEAU TECHNOLOGY OPERATIONS	Visionix	2023-06-16
PMN K202221 Luneau Technology Operations	VX650	2021-01-29
GUDID 03664188000909 LUNEAU TECHNOLOGY OPERATIONS	VISIONIX	2020-06-02
GUDID 03664188000046 LUNEAU TECHNOLOGY OPERATIONS	VISIONIX	2020-06-02
GUDID 03664188000039 LUNEAU TECHNOLOGY OPERATIONS	VISIONIX	2020-06-02
GUDID 03664188002200 LUNEAU TECHNOLOGY OPERATIONS	VISIONIX	2020-05-15
GUDID 03664188000886 LUNEAU TECHNOLOGY OPERATIONS	VISIONIX	2020-05-15
GUDID 03664188000879 LUNEAU TECHNOLOGY OPERATIONS	VISIONIX	2020-05-15
GUDID 03664188000862 LUNEAU TECHNOLOGY OPERATIONS	VISIONIX	2020-05-15
GUDID 03664188000855 LUNEAU TECHNOLOGY OPERATIONS	VISIONIX	2020-05-15
GUDID 03664188000831 LUNEAU TECHNOLOGY OPERATIONS	VISIONIX	2020-05-15
GUDID 03664188000824 LUNEAU TECHNOLOGY OPERATIONS	VISIONIX	2020-05-15
GUDID 03664188000817 LUNEAU TECHNOLOGY OPERATIONS	VISIONIX	2020-05-15
GUDID 03664188000800 LUNEAU TECHNOLOGY OPERATIONS	VISIONIX	2020-05-15
GUDID 03664188000787 LUNEAU TECHNOLOGY OPERATIONS	VISIONIX	2020-05-15
GUDID 03664188000770 LUNEAU TECHNOLOGY OPERATIONS	VISIONIX	2020-05-15
GUDID 03664188000763 LUNEAU TECHNOLOGY OPERATIONS	VISIONIX	2020-05-15
GUDID 03664188000756 LUNEAU TECHNOLOGY OPERATIONS	VISIONIX	2020-05-15
GUDID 03664188000107 LUNEAU TECHNOLOGY OPERATIONS	Luneau	2020-05-15
PMN K162067 | MXK LUNEAU TECHNOLOGY OPERATIONS	VX130	2017-04-25
PMN K162067 | MXK LUNEAU TECHNOLOGY OPERATIONS	VX130+	2017-04-25
PMN K162067 | MXK Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX130	2017-04-25
PMN K162067 | MXK Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX130	2017-04-25
PMN K162067 | MXK Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX130+	2017-04-25
PMN K162067 | MXK Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX130+	2017-04-25
PMN K162067 | HKX LUNEAU TECHNOLOGY OPERATIONS	VX130	2017-04-25
PMN K162067 | HKX LUNEAU TECHNOLOGY OPERATIONS	VX130+	2017-04-25
PMN K162067 | HKX Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX130	2017-04-25
PMN K162067 | HKX Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX130	2017-04-25
PMN K162067 | HKX Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX130+	2017-04-25
PMN K162067 | HKX Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX130+	2017-04-25
PMN K992836 | HJO LUNEAU TECHNOLOGY OPERATIONS	VX85	2016-08-09
PMN K992836 | HJO LUNEAU TECHNOLOGY OPERATIONS	VX80	2016-08-09
PMN K992836 | HJO LUNEAU TECHNOLOGY OPERATIONS	VX75	2016-08-09
PMN K992836 | HJO Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX85	2016-08-09
PMN K992836 | HJO Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX80	2016-08-09
PMN K992836 | HJO Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX75	2016-08-09
PMN K143086 | HKX LUNEAU TECHNOLOGY OPERATIONS	VX220	2015-06-02
PMN K143086 | HKX LUNEAU TECHNOLOGY OPERATIONS	VX120	2015-06-02
PMN K143086 | HKX LUNEAU TECHNOLOGY OPERATIONS	VX120+	2015-06-02
PMN K143086 | HKX LUNEAU TECHNOLOGY OPERATIONS	VX118	2015-06-02
PMN K143086 | HKX Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX220	2015-06-02
PMN K143086 | HKX Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX220	2015-06-02
PMN K143086 | HKX Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX120	2015-06-02
PMN K143086 | HKX Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX120	2015-06-02
PMN K143086 | HKX Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX120+	2015-06-02
PMN K143086 | HKX Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX120+	2015-06-02
PMN K143086 | HKX Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX118	2015-06-02
PMN K143086 | HKX Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX118	2015-06-02
HLM LUNEAU TECHNOLOGY OPERATIONS	VX40	2009-12-30
HLM LUNEAU TECHNOLOGY OPERATIONS	VX36	2009-12-30
HLM Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX40	2009-12-30
HLM Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX40	2009-12-30
HLM Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX36	2009-12-30
HLM Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX36	2009-12-30
HKN LUNEAU TECHNOLOGY OPERATIONS	VX65	2009-12-30
HKN LUNEAU TECHNOLOGY OPERATIONS	VX60	2009-12-30
HKN LUNEAU TECHNOLOGY OPERATIONS	VX55	2009-12-30
HKN LUNEAU TECHNOLOGY OPERATIONS	VX50	2009-12-30
HKN LUNEAU TECHNOLOGY OPERATIONS	EYEREFRACT	2009-12-30
HKN Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX65	2009-12-30
HKN Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX65	2009-12-30
HKN Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX60	2009-12-30
HKN Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX60	2009-12-30
HKN Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX55	2009-12-30
HKN Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX55	2009-12-30
HKN Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX50	2009-12-30
HKN Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX50	2009-12-30
HKN Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	EYEREFRACT	2009-12-30
HKN Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	EYEREFRACT	2009-12-30
PMN K023838 | HKY LUNEAU TECHNOLOGY OPERATIONS	LUNEAU TONOMETER SEPARATION PRISMS	2007-12-13
PMN K023838 | HKY Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	LUNEAU TONOMETER SEPARATION PRISMS	2007-12-13
HKO LUNEAU TECHNOLOGY OPERATIONS	VX90	2007-12-13
HKO LUNEAU TECHNOLOGY OPERATIONS	VX110	2007-12-13
HKO LUNEAU TECHNOLOGY OPERATIONS	VX100	2007-12-13
HKO LUNEAU TECHNOLOGY OPERATIONS	L67	2007-12-13
HKO LUNEAU TECHNOLOGY OPERATIONS	I.PROFILER PLUS	2007-12-13
HKO Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX90	2007-12-13
HKO Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX90	2007-12-13
HKO Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX110	2007-12-13
HKO Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX110	2007-12-13
HKO Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX100	2007-12-13
HKO Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX100	2007-12-13
HKO Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	L67	2007-12-13
HKO Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	L67	2007-12-13
HKO Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	I.PROFILER PLUS	2007-12-13
HKO Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	I.PROFILER PLUS	2007-12-13
HJC LUNEAU TECHNOLOGY OPERATIONS	ESTHESIOMETER	2007-12-13
HJC Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	ESTHESIOMETER	2007-12-13
HOX LUNEAU TECHNOLOGY OPERATIONS	VX25	2007-12-12
HOX LUNEAU TECHNOLOGY OPERATIONS	VX24	2007-12-12
HOX LUNEAU TECHNOLOGY OPERATIONS	VX22	2007-12-12
HOX LUNEAU TECHNOLOGY OPERATIONS	VX19	2007-12-12
HOX LUNEAU TECHNOLOGY OPERATIONS	LUNEAU CHART DISPLAY	2007-12-12
HOX Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX25	2007-12-12
HOX Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX24	2007-12-12
HOX Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX22	2007-12-12
HOX Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	VX19	2007-12-12
HOX Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	LUNEAU CHART DISPLAY	2007-12-12
HKW LUNEAU TECHNOLOGY OPERATIONS	OPHTHALMIC BAR PRISM	1985-03-10
HKW LUNEAU TECHNOLOGY OPERATIONS	LOOSE PRISM	1985-03-10
HKW Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	OPHTHALMIC BAR PRISM	1985-03-10
HKW Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	LOOSE PRISM	1985-03-10
HMH LUNEAU TECHNOLOGY OPERATIONS	RETINOSCOPY RACK L2	1984-10-08
HMH Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	RETINOSCOPY RACK L2	1984-10-08
HIT LUNEAU TECHNOLOGY OPERATIONS	NCT	1984-07-27
HIT LUNEAU TECHNOLOGY OPERATIONS	LANTHONY TESTS	1984-07-27
HIT LUNEAU TECHNOLOGY OPERATIONS	FARNSWORTH TESTS	1984-07-27
HIT Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	NCT	1984-07-27
HIT Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	LANTHONY TESTS	1984-07-27
HIT Joe Vulich [LUNEAU TECHNOLOGY OPERATIONS]	FARNSWORTH TESTS	1984-07-27