FDA 510(k) Applications for Medical Device:
Light Based Over The Counter Wrinkle Reduction
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K212275 | Aesthetic Technology Ltd. |
Unit 211 Europa Blvd. | Warrington | WA5 7TN | |
| K223919 | Bemer INT. AG |
Austrasse 15 | Triesen | 9495 | |
| K171323 | Biophotas Inc |
1000 E. Howell Ave. | Anaheim | CA | 92805 |
| K132613 | BIORENEW LABS, LLC |
2424 DEMPSTER DRIVE | CORALVILLE | IA | 52241 |
| K202442 | Carewear Corp. |
1225 Financial Blvd. | Reno | NV | 89502 |
| K120560 | Carol Cole Company |
16405 SUMMER SAGE RD | POWAY | CA | 92064 |
| K212947 | Carol Cole Company dba NuFACE |
1325 Sycamore Ave, Suite A | Vista | CA | 92081 |
| K222377 | CellReturn Co., LTD. |
237, Namdongseo-ro. Namdong-gu | Incheon | 21634 | |
| K151337 | Centre Light Solutions, LLC |
611 East Douglas Rd. Suite 108 | Mishawaka | IN | 46545 |
| K111454 | CYNOSURE, INC. |
5 CARLISLE ROAD | WESTFORD | MA | 01886 |
| K133473 | CYNOSURE, INC. |
5 CARLISLE ROAD | WESTFORD | MA | 01886 |
| K222685 | Dermal Photonics Corp |
153 Andover St, Ste 111 | Danvers | MA | 01923 |
| K163137 | Dermal Photonics Corporation |
5 Elm St, Suite 10 | Danvers | MA | 01923 |
| K241857 | Dongguan Boyuan Intelligent Technology Co., Ltd. |
Room 801, Building 3, No.3 Kuiqiao Road, Puxin Lake, Tangxia | Dongguan | 523719 | |
| K241203 | Dongguan Hunter Electronic Technology Co., Ltd. |
Room 301, Building 6, 74 Qiaodong Road, Tangxia Town | Guangdong | 523728 | |
| K242789 | Dongguan Laiguang Electronic Technology Co.,Ltd. |
Room201,NO.64,DongkangRoad,DalingshanTown | Dongguan | 523820 | |
| K214101 | Duplex International Trading Limited |
B1, 10/F, Block 2, Golden Dragon Ind Centre, 162-170 | Hong Kong | ||
| K124064 | ESPANSIONE MARKETING SPA |
VIA ALTOBELLI BONETTI 3A | IMOLA(BO) | 40026 | |
| K240378 | Foreo Inc. |
1525 E Pama Lane | Las Vegas | NV | 89119 |
| K241102 | Foreo Inc. |
1525 E Pama Lane | Las Vegas | NV | 89119 |
| K250880 | Foshan Guangyu Weilai Medical Equipment Co., Ltd. |
201, Block A, Zhongfa Zhaochuang Science and Technology Park | Foshan | 528226 | |
| K190443 | Galactic Beauty, LLC |
12 E 87 ST STE 1A | New York | NY | 10128 |
| K201107 | GTG Wellness Co., Ltd. |
767, Sinsu-ro, Suju-gu | Yongin-si | 16827 | |
| K223544 | Guangdong Newdermo Biotech Co.,Ltd |
Building C28. Huachuang Industrial Park, Jinshan Avenue | Guangzhou | 511450 | |
| K251042 | Guangzhou Ahead Intelligent Technology Co., Ltd. |
Room 505, Building 2, No.10, Industrial 1st Road, | Guangzhou | 511430 | |
| K110301 | HOME SKINOVATIONS LTD. |
TAVOR BULD. POB 533 | YOKNEAM ILLIT | 20692 | |
| K162784 | Home Skinovations Ltd. |
Tabor Building, Shaar Yokneam | Yoqneam Illit | 2069200 | |
| K221151 | Hunan Guangye Biotechnology Co., Ltd. |
Room 701, Jinhong Park Incubation Building, No.229, Tongzipo | Changsha City | 410006 | |
| K242382 | ISMART Developments Ltd |
129 Green Lanes | Birmingham | B73 5LT | |
| K231555 | iSMART Developments Ltd |
129 Green Lanes, Boldmere, Sutton Coldfield | Birmingham | B73 5LT | |
| K191629 | iSMART Marketing Svcs Ltd |
129 Green Lanes, Sutton Coldfield | Birmingham | B735LT | |
| K180856 | Johnson & Johnson Consumer, Inc. |
7050 Camp Hill Road | Fort Washington | PA | 19034 |
| K140471 | LA LUMIERE, LLC |
12101 CULLNE BLVD. SUITE A | HOUSTON | TX | 77047 |
| K212771 | LED Intellectual Properties LLC |
16552 Von Karman Ave | Irvine | CA | 92606 |
| K120775 | LED INTELLECTUAL PROPERTIES, LLC |
16552 VON KARMAN AVE. | IRVINE | CA | 92606 |
| K101190 | LED INTELLECTUAL PROPERTIES, LLC |
9832 CHESTERFIELD CIRCLE | SANTA ANA | CA | 92705 |
| K150098 | LED INTELLECTUAL PROPERTIES, LLC |
16552 VON KARMAN AVE. | IRVINE | CA | 92606 |
| K151336 | LED INTELLECTUAL PROPERTIES, LLC |
16552 VON KARMAN AVE. | IRVINE | CA | 92606 |
| K183247 | LED Technologies, Inc. |
6000 Greenwood Plaza Blvd., Suite 110 | Greenwood Village | CO | 80111 |
| K171390 | LED Technologies, Inc. |
6000 Greenwood Plaza Blvd., Suite 110 | Greenwood Village | CO | 80111 |
| K180320 | LED Technologies, Inc. |
6000 Greenwood Plaza Blvd., Suite 110 | Greenwood Village | CO | 80111 |
| K171386 | LED Technologies, Inc. |
6000 Greenwood Plaza Blvd., Suite 110 | Greenwood Village | CO | 80111 |
| K210965 | LED Technologies, Inc. |
12821 Starkey Rd., Suite 4900 | Largo | FL | 33773 |
| K221430 | LED Technologies, Inc. |
12821 Starkey Rd., Suite 4900 | Largo | FL | 33773 |
| K180445 | LED Technologies, Inc. |
6000 Greenwood Plaza Blvd., Suite 110 | Greenwood Village | CO | 80111 |
| K223482 | LED Technologies, Inc. |
12821 Starkey Rd., Suite 4900 | Largo | FL | 33773 |
| K172662 | LED Technologies, Inc. |
6000 Greenwood Plaza Blvd., Suite 110 | Greenwood Village | CO | 80111 |
| K101382 | LED TECHNOLOGIES, LLC |
4655 KIRKWOOD COURT | BOULDER | CO | 80301 |
| K141181 | LED TECHNOLOGIES, LLC |
2424 DEMPSTER DR. | CORALVILLE | IA | 52241 |
| K170984 | LG Electronics |
222 LG-ro Jinwi-myeon | Pyeongtaek-si | 17709 | |
| K183671 | LG Electronics, Inc. |
222 LG-ro Jinwi-myeon | Pyeongtaek-si | 17709 | |
| K062991 | LIGHT BIOSCIENCE, LLC |
555 THIRTEENTH STREET NW | WASHINGTON | DC | 20004 |
| K223893 | Light Tree Ventures Europe B.V. |
Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands | Hague | ||
| K221444 | Light Tree Ventures Europe B.V. |
Laan van Ypenburg 108, 2497 GC | The Hague | ||
| K221775 | Light Tree Ventures Europe B.V. |
Laan van Ypenburg 108, 2497 GC | Hague | ||
| K221946 | Light Tree Ventures Europe B.V. |
Laan van Ypenburg 108, 2497 GC | Hague | ||
| K230124 | Light Tree Ventures Europe B.V. |
Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands | Hague | 2500 | |
| K230042 | Light Tree Ventures Europe B.V. |
Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands | Hague | ||
| K210823 | LYMA Life Ltd. |
93 Gloucester Place | London | W1H 6JQ | |
| K243330 | LYMA Life Ltd. |
2nd Floor Edison House | London | NW1 5QT | |
| K180875 | Medtek Skincare, LLC |
3 Depot Street | Hudson Falls | NY | 12839 |
| K223147 | myBlend |
9 Rue du Commandant Pilot | Neuilly-sur-Seine | 92200 | |
| K200983 | Ningbo Hesi Electric Co., Ltd |
No.818-23-156 Qiming Rd, Yinzhou, Ningbo City Zhejiistrict, | Ningbo | 315000 | |
| K141308 | NUTRA LUXE MD, LLC |
5575 SANTA ROSA CT. | SPARKS | NV | 89436 |
| K172909 | Omm Imports d/b/a Zero Gravity |
9737 NW 41St Street | Doral | FL | 33178 |
| K152332 | OMM IMPORTS INC DBA ZERO GRAVITY |
1945 S OCEAN DR APT 509 HALLANDLE BEACH BLVD | HALLANDLE | FL | 33009 |
| K110735 | PHAROS LIFE CORPORATION |
555 THIRTEENTH ST., NW | WASHINGTON | DC | 20004 |
| K072459 | PHOTO THERAPEUTICS, INC. |
2720 LOKER AVENUE WEST | CARLSBAD | CA | 92010 |
| K181659 | Premier North America Inc. |
3301 SW 42nd St | Fort Lauderdale | FL | 33312-6828 |
| K213841 | Premier North America Inc. |
3301 SW 42nd Street | Ft Lauderdale | FL | 33312 |
| K233862 | Premier North America Inc. |
3301 SW 42nd St | Fort Lauderdale | FL | 33312-6828 |
| K092460 | PS ADVANCED ENGINEERING |
200 SOUTH GARFIELD AVE | ALHAMBRA | CA | 91801 |
| K133546 | PS ADVANCED ENGINEERING |
200 S Garfield Ave Ste 103 | Alhambra | CA | 91801 |
| K163329 | PULSADERM LLC |
12801 COMMONWEALTH DR. UNITS 2-6 | Fort Myers | FL | 33913 |
| K242796 | SharkNinja Operating, LLC |
89 A Street | Needham | MA | 02494 |
| K241718 | Shenzhen Aozemei Technology Co. Ltd |
3/F, Building 9, Tianfu 'an Industrial Park, lezhujiao | Shenzhen | 518128 | |
| K242385 | Shenzhen Borria Technology Co., Ltd |
501, Floor 5, Building 6, Industrial Zone, No.2015, Shenyan | Shenzhen | ||
| K233114 | Shenzhen Idea Light Limited |
3rd Floor, Block B, Shengdelan Industry Park, | Shenzhen | 518000 | |
| K202390 | Shenzhen Kaiyan Medical Co Ltd |
40A Fuxin Road, Fuyong Subdistrict, BaoAn District | Shenzhen | 518101 | |
| K213024 | Shenzhen Kaiyan Medical Co Ltd |
40A Fuxin Road, Fuyong Subdistrict, | Shenzhen | 518000 | |
| K220168 | Shenzhen Kaiyan Medical Co Ltd |
40A Fuxin Road Fuyong Subdistrict BaoAn District, | Shenzhen | 518101 | |
| K250966 | Shenzhen Kaiyan Medical Equipment Co., Ltd |
Building#3 and Building#5, 40th of Fuxin Street, | Shenzhen | 518103 | |
| K242593 | Shenzhen Kaiyan Medical Equipment Co., Ltd |
Building#3 and Building#5, 40th of Fuxin Street | Shenzhen | 518103 | |
| K241947 | Shenzhen Kaiyan Medical Equipment Co., Ltd |
Building#3 and Building#5, 40th of Fuxin Street, | Shenzhen | 518103 | |
| K240089 | Shenzhen Kaiyan Medical Equipment Co., Ltd |
Building#3 and Building#5, 40th of Fuxin Street, Huaide | Shenzhen | 518103 | |
| K241933 | Shenzhen Kaiyan Medical Equipment Co., Ltd |
Building #3 and Building #5, 40th of Fuxin Street | Shenzhen | 518103 | |
| K250761 | SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD |
Building #3, and Building#5 40th of Fuxin street, | ShenZhen | 518003 | |
| K233556 | Shenzhen Kaiyan Medical Equipment Co., Ltd |
Building#3 and Building#5, 40th of Fuxin Street | Shenzhen | 510530 | |
| K232863 | Shenzhen Kaiyan Medical Equipment Co., Ltd |
Building#3 and Building#5, 40th of Fuxin Street | Shenzhen | 518103 | |
| K250532 | Shenzhen Kaiyan Medical Equipment Co., Ltd |
Building#3 and Building#5, 40th of Fuxin Street, | Shenzhen | 518103 | |
| K242700 | Shenzhen Nuon Medical Equipment Co., Ltd |
1st Floor-3rd Floor, No. 27-2, Xintang Rd, Xintian Community | Shenzhen | 518000 | |
| K242151 | Shenzhen Nuon Medical Equipment Co., Ltd |
1F-3F, No.27-2, Xintang Rd, Xintian Comm, Fuhai Str, | Shenzhen | 518000 | |
| K250413 | Shenzhen Perfect Idea Technology Limited |
4F, Building 1, Fuhua Industrial Park, Tangwei, | Shenzhen | 518103 | |
| K244020 | Shenzhen Qianyu Technology Co., Ltd. |
Room 601, HanÆs Technology Center. No.9988, Shennan Avenue, | Shenzhen | 518000 | |
| K240360 | Shenzhen Qianyu Technology Co., Ltd. |
Room 601, Han's Technology Center. No.9988, Shennan Avenue | Shenzhen | 518000 | |
| K243423 | Shenzhen Rainbow Technology Co., Ltd. |
5th floor, Building C, Fenda Technology Innovation Park, | Shenzhen | 518000 | |
| K243040 | Shenzhen Siken 3D Technology Development Co., Ltd. |
4th Building,No.33 Left East Avenue,Songgang, | Shenzhen | 518105 | |
| K230351 | Shenzhen SUNGPO HI-TECH Electronic Co., Ltd |
806 Chuangke Building, No.72-6 Huanguan South Road | Shenzhen | 518000 | |
| K250830 | Shenzhen Sungrow LED Technology Co., Ltd. |
3F 2# Factory BIdg (Phase I) , Bangkai Sci & Tech lnd Park | Shenzhen | 518000 | |
| K243978 | Shenzhen Sunsred Technology Co.,Ltd |
201, No. 22, Shijing Road, Fumin Community, Fucheng Street | Shenzhen | ||
| K243492 | Shenzhen Ulike Smart Electronics Co., Ltd. |
810, Building 1, Xunmei Science and Technology Plaza, No. 8 | Shenzhen | 518000 | |
| K242638 | Shenzhen Walton Technology Co., Ltd. |
Room 801, Jiaxiye Plaza, No. 318 Minzhi Avenue, | Shenzhen City | 518131 | |
| K112362 | SILVER BAY, LLC |
1131 ANTHEM VIEW LANE | KNOXVILLE | TN | 37922 |
| K130225 | SILVERBAY LLC, D/B/A QUASAR BIO-TECH |
2424DEMPSTER DRIVE | CORALVILLE | IA | 52241 |
| K232795 | STG24 CO.,LTD. |
237, Namdongseo-Ro. Namdong-Gu, | Incheon | 21634 | |
| K161849 | Tanda Beauty Canada Inc. |
11-380 Jamieson Parkway | Cambridge | ||
| K230293 | Therabody, Inc. |
6100 Wilshire Blvd, Suite 200 | Los Angeles | CA | 90048 |
| K212155 | Theragun, Inc. |
6100 Wilshire Blvd, Suite 200 | Los Angeles | CA | 90048 |
| K133896 | TROPHY SKIN, INC. |
2424 DEMPSTER DRIVE | CORALVILLE | IA | 52241 |
| K250125 | XPLR Ltd. |
Ben ami 6 st, Tel Aviv, Israel | Ben ami 6 st | ||
| K213285 | Y & J Bio Co., Ltd. |
B-916, 947, Hanam-daero | Hanam-si | 12982 | |
| K223278 | Y&J BIO Co., Ltd. |
B-916, 947, Hanam-daero | Hanam-si | 12982 | |
| K220064 | YRS Group Inc |
5151 S Procyon St Suite 105 | Las Vegas | NV | 89118 |
| K210954 | YRS Group Inc. |
4480 Delancey Dr Ste 14 | Las Vegas | NV | 89103 |
| K162489 | Zhongshan Bisen Plastic Electronic Products Co.,Ltd. |
F2,Bldg1,No.8,Dongzhen North Rd,Zhangjiabian 1st vil | Zhong Shan | 528437 |
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