Ray Co L T D

FDA Filings

This page includes the latest FDA filings for Ray Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3010445368
• FEI Number: 3010445368
• Name: Kevin Cho
• Owner & Operator: Ray Co., Ltd,
• Contact Address: 332-7, Samsung 1-ro ; Hwaseong-si KR-41 Gyeonggido 445-330 KR
• Official Correspondent:
  • Seho Lee
  • 082-070-7601-0275
• US Agent:
  • Kevin Cho
  • RAY AMERICA INC.
  • 800 9764586
  • kevin.cho@rayamerica.com
• Importing Logistics Registration:
  • Importer: Firas Bukai
  • Address: 57 Blue oat ; Irvine, CA 92620 UNITED STATES
  • Email Address: stylishsmile@yahoo.com
  • Phone: 1 714 5537427
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 725 River Road, Ste 118 ; Edgewater, NJ 07020 US
• Establishment Type:
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device
  • Foreign Private Label Distributor

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
GUDID 08800003000234 Ray Co., Ltd	RAYSCAN α-Expert3D	2023-09-15
GUDID 08800003000227 Ray Co., Ltd	RAYSCAN α-Expert3D	2023-09-15
GUDID 08800003000210 Ray Co., Ltd	RAYSCAN α-Expert3D	2023-09-15
GUDID 08800003000203 Ray Co., Ltd	RAYSCAN α-Expert3D	2023-09-15
GUDID 08800003004324 Ray Co., Ltd	RAYPreMiere	2023-04-25
GUDID 08800003004317 Ray Co., Ltd	RAYPreMiere	2023-04-25
GUDID 08800003004300 Ray Co., Ltd	RAYPreMiere	2023-04-25
GUDID 08800003004294 Ray Co., Ltd	RAYPreMiere	2023-04-25
GUDID 08800003004287 Ray Co., Ltd	RAYPreMiere	2023-04-25
GUDID 08800003004270 Ray Co., Ltd	RAYPreMiere	2023-04-25
GUDID 08800003004201 Ray Co., Ltd	RAYSCAN Studio	2023-04-12
GUDID 08800003004195 Ray Co., Ltd	RAYSCAN Studio	2023-04-12
GUDID 08800003004188 Ray Co., Ltd	RAYSCAN Studio	2023-04-12
GUDID 08800003004171 Ray Co., Ltd	RAYSCAN Studio	2023-04-12
GUDID 08800003004164 Ray Co., Ltd	RAYSCAN Studio	2023-04-12
GUDID 08800003004157 Ray Co., Ltd	RAYSCAN Studio	2023-04-12
GUDID 08800003004140 Ray Co., Ltd	RAYSCAN Studio	2023-04-12
GUDID 08800003004133 Ray Co., Ltd	RAYSCAN Studio	2023-04-12
GUDID 08800003004126 Ray Co., Ltd	RAYSCAN Studio	2023-04-12
GUDID 08800003004119 Ray Co., Ltd	RAYSCAN Studio	2023-04-12
GUDID 08800003004102 Ray Co., Ltd	RAYSCAN Studio	2023-04-12
GUDID 08800003004096 Ray Co., Ltd	RAYSCAN Studio	2023-04-12
GUDID 08800003004089 Ray Co., Ltd	RAYSCAN Studio	2023-04-12
GUDID 08800003004072 Ray Co., Ltd	RAYSCAN Studio	2023-04-12
GUDID 08800003004065 Ray Co., Ltd	RAYSCAN Studio	2023-04-12
GUDID 08800003004058 Ray Co., Ltd	RAYSCAN Studio	2023-04-12
GUDID 08800003004041 Ray Co., Ltd	RAYSCAN Studio	2023-04-12
GUDID 08800003004034 Ray Co., Ltd	RAYSCAN Studio	2023-04-12
GUDID 08800003004027 Ray Co., Ltd	RAYSCAN Studio	2023-04-12
GUDID 08800003004010 Ray Co., Ltd	RAYSCAN Studio	2023-04-12
GUDID 08800003002023 Ray Co., Ltd	RIOSensor	2023-04-12
GUDID 08800003002016 Ray Co., Ltd	RIOSensor	2023-04-12
GUDID 08800003001279 Ray Co., Ltd	RAYSCAN α+	2023-04-12
GUDID 08800003001262 Ray Co., Ltd	RAYSCAN α+	2023-04-12
GUDID 08800003001255 Ray Co., Ltd	RAYSCAN α+	2023-04-12
GUDID 08800003001248 Ray Co., Ltd	RAYSCAN α+	2023-04-12
GUDID 08800003001231 Ray Co., Ltd	RAYSCAN α+	2023-04-12
GUDID 08800003001224 Ray Co., Ltd	RAYSCAN α+	2023-04-12
GUDID 08800003001217 Ray Co., Ltd	RAYSCAN α+	2023-04-12
GUDID 08800003001200 Ray Co., Ltd	RAYSCAN α+	2023-04-12
GUDID 08800003001194 Ray Co., Ltd	RAYSCAN α+	2023-04-12
GUDID 08800003001187 Ray Co., Ltd	RAYSCAN α +	2023-04-12
GUDID 08800003001170 Ray Co., Ltd	RAYSCAN α+	2023-04-12
GUDID 08800003001163 Ray Co., Ltd	RAYSCAN α+	2023-04-12
GUDID 08800003001156 Ray Co., Ltd	RAYSCAN α+	2023-04-12
GUDID 08800003001149 Ray Co., Ltd	RAYSCAN α+	2023-04-12
GUDID 08800003001132 Ray Co., Ltd	RAYSCAN α+	2023-04-12
GUDID 08800003001125 Ray Co., Ltd	RAYSCAN α+	2023-04-12
GUDID 08800003001118 Ray Co., Ltd	RAYSCAN α+	2023-04-12
GUDID 08800003001101 Ray Co., Ltd	RAYSCAN α+	2023-04-12
GUDID 08800003001095 Ray Co., Ltd	RAYSCAN α+	2023-04-12
GUDID 08800003001088 Ray Co., Ltd	RAYSCAN α+	2023-04-12
GUDID 08800003001071 Ray Co., Ltd	RAYSCAN α+	2023-04-12
GUDID 08800003001064 Ray Co., Ltd	RAYSCAN α+	2023-04-12
GUDID 08800003001057 Ray Co., Ltd	RAYSCAN α+	2023-04-12
GUDID 08800003001040 Ray Co., Ltd	RAYSCAN α+	2023-04-12
GUDID 08800003001033 Ray Co., Ltd	RAYSCAN α+	2023-04-12
GUDID 08800003001026 Ray Co., Ltd	RAYSCAN α+	2023-04-12
GUDID 08800003001019 Ray Co., Ltd	RAYSCAN α+	2023-04-12
GUDID 08800003000197 Ray Co., Ltd	RAYSCAN α-Expert3D	2023-04-12
GUDID 08800003000180 Ray Co., Ltd	RAYSCAN α-Expert3D	2023-04-12
GUDID 08800003000173 Ray Co., Ltd	RAYSCAN α-Expert3D	2023-04-12
GUDID 08800003000166 Ray Co., Ltd	RAYSCAN α-Expert3D	2023-04-12
GUDID 08800003000159 Ray Co., Ltd	RAYSCAN α-Expert3D	2023-04-12
GUDID 08800003000142 Ray Co., Ltd	RAYSCAN α	2023-04-12
GUDID 08800003000135 Ray Co., Ltd	RAYSCAN α	2023-04-12
GUDID 08800003000128 Ray Co., Ltd	RAYSCAN α	2023-04-12
GUDID 08800003000111 Ray Co., Ltd	RAYSCAN α	2023-04-12
GUDID 08800003000104 Ray Co., Ltd	RAYSCAN α	2023-04-12
GUDID 08800003000098 Ray Co., Ltd	RAYSCAN α	2023-04-12
GUDID 08800003000081 Ray Co., Ltd	RAYSCAN α	2023-04-12
GUDID 08800003000074 Ray Co., Ltd	RAYSCAN α	2023-04-12
GUDID 08800003000067 Ray Co., Ltd	RAYSCAN α	2023-04-12
GUDID 08800003000050 Ray Co., Ltd	RAYSCAN α	2023-04-12
GUDID 08800003000043 Ray Co., Ltd	RAYSCAN α	2023-04-12
GUDID 08800003000036 Ray Co., Ltd	RAYSCAN α	2023-04-12
GUDID 08800003000029 Ray Co., Ltd	RAYSCAN α	2023-04-12
GUDID 08800003001446 Ray Co., Ltd	RAYSCAN α+	2023-02-22
GUDID 08800003001439 Ray Co., Ltd	RAYSCAN α+	2023-02-22
GUDID 08800003001422 Ray Co., Ltd	RAYSCAN α+	2023-02-22
GUDID 08800003001415 Ray Co., Ltd	RAYSCAN α+	2023-02-22
GUDID 08800003001408 Ray Co., Ltd	RAYSCAN α+	2023-02-22
GUDID 08800003001392 Ray Co., Ltd	RAYSCAN α+	2023-02-22
GUDID 08800003001385 Ray Co., Ltd	RAYSCAN α+	2023-02-22
GUDID 08800003001378 Ray Co., Ltd	RAYSCAN α+	2023-02-22
GUDID 08800003001361 Ray Co., Ltd	RAYSCAN α+	2023-02-22
GUDID 08800003001354 Ray Co., Ltd	RAYSCAN a+	2023-02-22
GUDID 18800003006042 Ray Co., Ltd	RAYDENT C&B	2022-11-11
GUDID 18800003006035 Ray Co., Ltd	RAYDENT C&B	2022-11-11
GUDID 18800003006028 Ray Co., Ltd	RAYDENT C&B	2022-11-11
GUDID 18800003006011 Ray Co., Ltd	RAYDENT C&B	2022-11-11
GUDID 18800003006004 Ray Co., Ltd	RAYDENT C&B	2022-11-11
GUDID 08800003006175 Ray Co., Ltd	RAYDENT SG	2022-11-11
GUDID 08800003006168 Ray Co., Ltd	RAYDENT SG	2022-11-11
GUDID 08800003006151 Ray Co., Ltd	RAYDENT SG	2022-11-11
GUDID 08800003006144 Ray Co., Ltd	RAYDENT SG	2022-11-11
GUDID 08800003006083 Ray Co., Ltd	RAYDENT C&B	2022-11-11
GUDID 08800003006076 Ray Co., Ltd	RAYDENT C&B	2022-11-11
GUDID 08800003006069 Ray Co., Ltd	RAYDENT C&B	2022-11-11
GUDID 08800003006052 Ray Co., Ltd	RAYDENT C&B	2022-11-11
PMN K213226 RAY Co., Ltd	RCT700	2021-11-29
PMN K211105 Ray Co., Ltd.	Ear-Friendly Mask	2021-05-17
OEA Kevin Cho [Ray Co., Ltd,]	R-GUARD3000	2020-04-09
PMN K192737 | OAS Kevin Cho [Ray Co., Ltd,]	RAYSCAN Studio	2019-10-23
PMN K192737 | OAS Kevin Cho [Ray Co., Ltd,]	RAYSCAN S	2019-10-23
PMN K192737 RAY CO., Ltd	RCT800	2019-10-22
PMN K070464 | LLZ Kevin Cho [Ray Co., Ltd,]	OnDemand3DTM	2019-06-28
PMN K190812 | OAS Kevin Cho [Ray Co., Ltd,]	RAYSCAN ?-Expert3D	2019-05-02
PMN K190812 RAY Co., Ltd	RAYSCAN A-Expert3D	2019-04-24
EHY Kevin Cho [Ray Co., Ltd,]	RIT-SU	2018-12-20
EHY Kevin Cho [Ray Co., Ltd,]	RIT-SL	2018-12-20
EHY Kevin Cho [Ray Co., Ltd,]	RIT-PB	2018-12-20
EHY Kevin Cho [Ray Co., Ltd,]	RIT-PA	2018-12-20
EHY Kevin Cho [Ray Co., Ltd,]	RIT-MU	2018-12-20
EHY Kevin Cho [Ray Co., Ltd,]	RIT-ML	2018-12-20
EHY Kevin Cho [Ray Co., Ltd,]	RIT-LU	2018-12-20
EHY Kevin Cho [Ray Co., Ltd,]	RIT-LL	2018-12-20
PMN K182805 | OAS Kevin Cho [Ray Co., Ltd,]	RCT800	2018-12-16
PMN K182805 | OAS Kevin Cho [Ray Co., Ltd,]	RAYSCAN Studio	2018-12-16
PMN K182805 RAY Co., Ltd	RCT800	2018-12-14
PMN K182614 | OAS Kevin Cho [Ray Co., Ltd,]	RCT700	2018-10-22
PMN K182614 | OAS Kevin Cho [Ray Co., Ltd,]	RAYSCAN A+	2018-10-22
PMN K182614 RAY Co.,Ltd	RCT700	2018-10-16
PMN K181452 Ray Co., Ltd.	RCT800	2018-07-27
NDP Kevin Cho [Ray Co., Ltd,]	RAYDENT SG	2017-05-18
ELJ Kevin Cho [Ray Co., Ltd,]	RAYDENT C&B	2017-05-18
EBH Kevin Cho [Ray Co., Ltd,]	RAYDENT DM	2017-05-18
PMN K160525 RAY CO.,LTD	RCT700	2016-06-20
PMN K160788 | MUH Kevin Cho [Ray Co., Ltd,]	RPS500	2016-04-28
PMN K160788 | MUH Kevin Cho [Ray Co., Ltd,]	RIOScan	2016-04-28
PMN K160788 RAY CO., Ltd	RIOScan (RPS500)	2016-04-15
PMN K142058 | MUH Kevin Cho [Ray Co., Ltd,]	Rayscan A-Expert	2015-04-24
PMN K142058 RAY CO., LTD	RAYSCAN A-EXPERT	2015-04-22
PMN K142247 RAY CO., LTD	RAYSCAN A-EXPERT 3D	2015-04-17
PMN K143000 | MQB Kevin Cho [Ray Co., Ltd,]	RIS500	2015-01-26
PMN K143000 RAY CO.,LTD	RIS500	2015-01-23
PMN K131695 RAY CO., LTD	RAYSCAN A-EXPERT 3D	2013-11-01
PMN K131693 RAY CO., LTD	RAYSCAN A-EXPERT	2013-11-01
PMN K122918 RAY CO., LTD	RAYSCAN A-EXPERT	2013-03-15
PMN K122981 RAY CO., LTD	RAYSCAN A-EXPERT 3D	2013-03-12

Similar & Related FDA Registered Companies

• Rayco Electronic Ltd.
• Rayence Co., Ltd.
• Raymond (nantong) protection supplies co., LTD
• RAYMOND CHU INTL. (MACAO COMMERCIAL OFFSHORE) LTD
• RAYMOND CONSUMER CARE PRIVATE LIMITED
• RAYMAN SPECO CO., LTD.
• RAYNER INTRAOCULAR LENSES LTD.1-2 Sackville Trading Estate,sackville Roadhove, East Sussex BN3 7 PMA NumberP060011 Supplement NumberS030 Date Received07/21/2022 Decision Date08/15/2022 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	983FF	RAY CO., LTD.
CAGE Code	983FF	RAY CO., LTD.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018071850741	Pusan,South Korea -> Los Angeles, California	RAYSCAN ALPHA 3D EDGE	10 PKG
2018060927276	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	20 PKGS OF RAYSCAN ALPHA-3D EDGE [RCT700]RAY SCAN ALPHA+130 SC UPGRADE KIT INVOICE NO.: R S180509-001	20 PKG
201805147631	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	RAYSCAN ALPHA EXPERT SC UPGRADE KIT INVOICE NO.: RS180404-001	20 PKG
2018051061889	Pusan,South Korea -> Long Beach, California	10 PKGS OF RAYSCAN ALPHA-EXPERT INVOICE NO. : RS180418-001	10 PKG
2018040554083	Pusan,South Korea -> Long Beach, California	26 PKGS OF RAYSCAN ALPHA-EXPERT SC UPGRADE K IT RAYSCAN ALPHA-EXPERT 3D INVOICE NO.: RS18 0321-001	26 PKG
2018031548122	Pusan,South Korea -> Los Angeles, California	24 PKGS OF RAYSCAN ALPHA-EXPERT SC UPGRADE K IT RAYSCAN ALPHA-3D EDGE INVOICE NO.: RS1802 27-002	24 PKG
2018022316523	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	23 PKGS OF RAY DENTAL X-RAY SYSTEM RAYSCAN A LPHA-EXPERT SC UPGRADE KIT BROCHURE EVENT BAG INVOICE NO.: RS180123-001	23 PKG
2018013074257	Pusan,South Korea -> Los Angeles, California	10 PKGS OF RAY DENTAL X-RAY SYSTEM RAYSCAN A LPHA - EXPERT INVOICE NO.: RS180111-002	10 PKG