Rayence Co L T D

FDA Filings

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

KOREA REP OF

KOREA EXCHANGE (KOSDAQ)

228850

DUNS 557804458

FDA Registration(s)

• Registration Number: 3009048384
• FEI Number: 3009048384
• Name: Dave Kim
• Owner & Operator: Rayence Co., Ltd.
• Contact Address: 14, Samsung 1-ro 1-gil ; Hwaseong-si KR-41 Gyeonggido 18449 KR
• US Agent:
  • Dave Kim
  • Mtech Group
  • 713 4672607
  • 713 4648880
  • davekim@mtech-inc.net
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 12946 Kimberley Ln ; Houston, TX 77079 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 08800018602249 Rayence Co., Ltd.	1717WCE-GF	2024-09-27
GUDID 08800018602232 Rayence Co., Ltd.	1717WCE-HS	2024-09-27
GUDID 08800018602225 Rayence Co., Ltd.	1717WCE-HR	2024-09-27
GUDID 08800018602218 Rayence Co., Ltd.	1717WCE	2024-09-27
GUDID 08800018602201 Rayence Co., Ltd.	0909FCC-HS	2024-03-29
GUDID 08800018602195 Rayence Co., Ltd.	0909FCC	2024-03-29
GUDID 08800018602171 Rayence Co., Ltd.	1417WCE-GF	2023-07-07
GUDID 08800018602164 Rayence Co., Ltd.	1417WCE-HS	2023-07-07
GUDID 08800018602157 Rayence Co., Ltd.	1417WCE-HR	2023-07-07
GUDID 08800018602140 Rayence Co., Ltd.	1417WCE	2023-07-07
GUDID 08800018601457 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601440 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601433 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601426 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601419 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601402 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601396 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601389 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601372 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601365 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601358 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601341 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601334 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601327 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601310 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601303 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601297 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601280 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601273 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601266 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601259 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601242 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601235 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601228 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601211 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601204 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601198 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601181 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601174 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601167 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601150 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601143 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601136 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601129 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601112 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601105 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601099 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601082 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601075 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601068 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601051 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601044 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601037 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601020 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601013 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018601006 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018600993 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018600986 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018600979 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018600962 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018600955 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018600948 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018600931 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
GUDID 08800018600924 Rayence Co., Ltd.	Vatech Clismile	2022-06-08
PMN K220689 Rayence Co.,Ltd	Vatech Clismile	2022-05-06
GUDID 08800018600900 Rayence Co., Ltd.	0909FCB	2021-11-08
PMN K212753 Rayence Co., Ltd	0909FCB, 1212FCA	2021-10-18
GUDID 08800018600726 Rayence Co., Ltd.	2430MCA	2021-07-06
PMN K202902 Rayence Co., Ltd	2430MCA With Xmaru W	2021-06-21
GUDID 08800018600887 Rayence Co., Ltd.	1717FCC	2021-05-12
PMN K210985 Rayence Co., Ltd	1717FCC	2021-04-28
GUDID 08800018600634 Rayence Co., Ltd.	1717SGV	2020-08-06
GUDID 08800018600627 Rayence Co., Ltd.	1717SCV	2020-08-06
GUDID 08800018600610 Rayence Co., Ltd.	XmaruView V1	2020-08-03
GUDID 08800018600603 Rayence Co., Ltd.	Xmaru Chiroview	2020-08-03
GUDID 08800018600597 Rayence Co., Ltd.	Xmaru Podview	2020-08-03
GUDID 08800018600580 Rayence Co., Ltd.	Xmaru Pro	2020-08-03
PMN K201796 Rayence Co., Ltd.	1717SCV, 1717SGV	2020-07-23
GUDID 08800018600559 Rayence Co., Ltd.	1417WCC	2020-03-16
GUDID 08800018600566 Rayence Co., Ltd.	1012WGC	2019-05-07
GUDID 08800018600542 Rayence Co., Ltd.	1417WGC	2019-05-07
GUDID 08800018600535 Rayence Co., Ltd.	1717SCC	2019-05-07
GUDID 08800018600528 Rayence Co., Ltd.	1717SGC	2019-05-07
GUDID 08800018600511 Rayence Co., Ltd.	1717WGC	2019-05-07
GUDID 08800018600504 Rayence Co., Ltd.	1717WCC	2019-05-07
GUDID 08800018600498 Rayence Co., Ltd.	1012WCC	2019-05-07
GUDID 08800018600368 Rayence Co., Ltd.	1717SCN	2019-05-07
GUDID 08800018600351 Rayence Co., Ltd.	1717SGN	2019-05-07
GUDID 08800018600344 Rayence Co., Ltd.	1417WCC	2019-05-07
GUDID 08800018600337 Rayence Co., Ltd.	1417WGC	2019-05-07
GUDID 08800018600320 Rayence Co., Ltd.	1717G	2019-05-07
GUDID 08800018600313 Rayence Co., Ltd.	910SGA	2019-05-07
GUDID 08800018600306 Rayence Co., Ltd.	1417WCA	2019-05-07
GUDID 08800018600290 Rayence Co., Ltd.	1417WGA	2019-05-07
GUDID 08800018600283 Rayence Co., Ltd.	1012WCA	2019-05-07
GUDID 08800018600276 Rayence Co., Ltd.	1417PCA	2019-05-07
GUDID 08800018600269 Rayence Co., Ltd.	1417PGA	2019-05-07
GUDID 08800018600252 Rayence Co., Ltd.	1717SCC	2019-05-07
GUDID 08800018600245 Rayence Co., Ltd.	1717SGC	2019-05-07
GUDID 08800018600238 Rayence Co., Ltd.	1210SGA	2019-05-07
PMN K190866 Rayence Co., Ltd	XmaruView V1 (Xmaru Chiroview, Xmaru Podview)	2019-04-30
PMN K183478 | LLZ Dave Kim [Rayence Co., Ltd.]	ClearON Mobile	2019-03-06
PMN K183478 Rayence Co.,Ltd	ClearON Mobile	2019-03-01
PMN K171418 | MQB Dave Kim [Rayence Co., Ltd.]	1417WCC_140um	2017-06-28
PMN K171418 | MQB Dave Kim [Rayence Co., Ltd.]	1417WCC_127um	2017-06-28
PMN K171418 Rayence Co., Ltd	1417WCC_127um And1417WCC_140um	2017-06-12
PMN K171417 Rayence Co., Ltd	1417WGC_127um And 1417WGC_140um	2017-06-12
PMN K171420 Rayence Co., Ltd	1717SCC_127um And 1717SCC_140um	2017-06-09
PMN K171419 Rayence Co., Ltd	1717SGC_127um And 1717SGC_140um	2017-06-09
PMN K162519 RAYENCE CO., LTD	1717WCC / 1717WGC	2016-10-06
PMN K162518 RAYENCE CO., LTD.	1012WCC, 1012WGC	2016-10-06
PMN K160579 | LLZ Dave Kim [Rayence Co., Ltd.]	XmaruView V1	2016-05-12
PMN K160579 | LLZ Dave Kim [Rayence Co., Ltd.]	Xmaru Pro	2016-05-12
PMN K160579 | LLZ Dave Kim [Rayence Co., Ltd.]	Xmaru Podview	2016-05-12
PMN K160579 | LLZ Dave Kim [Rayence Co., Ltd.]	Xmaru PACS	2016-05-12
PMN K160579 | LLZ Dave Kim [Rayence Co., Ltd.]	Xmaru Chiroview	2016-05-12
PMN K160579 RAYENCE CO., LTD	Xmaru View V1 And Xmaru PACS, Medical Image Processing Software	2016-04-08
PMN K153060 RAYENCE CO., LTD	Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S	2015-11-10
PMN K151707 RAYENCE CO., LTD	EzSensor Soft, EzSensor Soft I, EzSensor Bio, And EzSensor Bio I	2015-07-19
PMN K150797 Rayence Co., Ltd	Digital Dental Intra Oral Sensor, EzSensor Smart	2015-05-01
PMN K150150 Rayence Co., Ltd	1717SGN / 1717SCN Digital Flat Panel X-ray Detector	2015-03-27
PMN K143753 Rayence Co., Ltd	Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio	2015-03-10
PMN K141566 RAYENCE CO., LTD	SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC	2014-07-16
PMN K141563 RAYENCE CO., LTD	SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC	2014-07-16
PMN K140060 RAYENCE CO., LTD	DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A	2014-05-13
PMN K140056 RAYENCE CO., LTD	DIGITAL DENTAL INTRA ORAL SENSOR; HDI 1000, HDI 1000A	2014-05-13
PMN K140646 RAYENCE CO., LTD	DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G	2014-04-11
PMN K133409 RAYENCE CO., LTD	DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA	2014-02-21
PMN K131114 RAYENCE CO., LTD	DIGITAL FLAT PANEL X-RAY DETECTOR	2013-09-17
PMN K130935 RAYENCE CO., LTD	DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA	2013-07-02
PMN K123345 RAYENCE CO., LTD	DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA	2013-03-12
PMN K122928 RAYENCE CO., LTD	DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA	2013-01-30
PMN K122919 RAYENCE CO., LTD	DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA	2013-01-01
PMN K122173 RAYENCE CO., LTD	DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC	2012-10-19
PMN K122182 RAYENCE CO., LTD	DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC	2012-08-16
PMN K113630 RAYENCE CO., LTD	DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA	2011-12-29

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020051341080	Pusan,South Korea -> Long Beach, California	PARTS FOR X-RAY TOTAL 79 CTNS OF 50 CTNS OF PARTS OF APPARATUS BASED ON THE USE OF X-RAY 29 CTNS OF FLAT PANEL DETECTOR	79 CTN
2020042260801	Pusan,South Korea -> Long Beach, California	PARTS OF APPARATUS BASED ON THE USE OF 87 CTNS OF 70 CTNS OF PARTS OF APPARATUS BASED ON THE USE OF X-RAY INVOICE NO. RY200331-SJ007 P/O NO 1409, 1426	87 CTN
2020030527991	Pusan,South Korea -> Long Beach, California	X-RAY HI TNSN GENR CNTR PNL DSK EXM TRTMNT 29 PKGS OF X RAY SYSTEM EQUIPMENT SUBSTITUTED AT CARRIER S CONVENIENCE.	29 PKG
2020021947012	Pusan,South Korea -> Long Beach, California	X-RAY HI TNSN GENR CNTR PNL DSK EXM TRTMNT 30 PKGS OF X-RAY SYSTEM(XR5 6WAY)	30 PKG
2019122837463	Pusan,South Korea -> Los Angeles, California	X-RAY HI TNSN GENR CNTR PNL DSK EXM TRTMNT 16 PACKAGES OF X-RAY SYSTEM(XR5 4WAY) LSS-1000(WITHOUT BUCKY) LSS-2000(WITH RAIL) TABLE TOP	16 PKG
2019122357738	Pusan,South Korea -> Los Angeles, California	PARTS FOR X- RAY SYSTEM	16 PKG
2019121952142	Pusan,South Korea -> Los Angeles, California	X-RAY HI TNSN GENR CNTR PNL DSK EXM TRTMNT 33 CRATES OF PARTS FOR X-RAY SYSTEM EQUIPMENT SUBSTITUTED AT CARRIER S CONVENIENCE.	33 CRT
2019121743753	Pusan,South Korea -> Los Angeles, California	X-RAY HI TNSN GENR CNTR PNL DSK EXM TRTMNT 10 CRATES OF X-RAY SYSTEM	10 CRT