FDA 510(k) Applications for Medical Device:
Laser, Comb, Hair
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K193008 | Advihair S.R.L. |
Via Benini 11 | Zola Predosa | 40069 | |
| K242619 | Apira Science Inc |
409 Edmon Rd. NE Suite C | Albuquerque | NM | 87107 |
| K141567 | APIRA SCIENCE, INC. |
641 SHUNPIKE RD, STE 311 | CHATHAM | NJ | 07928 |
| K122248 | APIRA SCIENCE, INC. |
641 SHUNPIKE RD, STE 311 | CHATHAM | NJ | 07928 |
| K140931 | APIRA SCIENCE, INC. |
641 SHUNPIKE RD, STE 311 | CHATHAM | NJ | 07928 |
| K220543 | Auxo Hair, LLC |
16300 SW 101 Ave | Miami | FL | 33157 |
| K211038 | Biophotas INC |
1000 E. Howell Ave., Ste A | Anaheim | CA | 92805 |
| K192012 | Capillus |
1715 NW 82nd Ave. | Doral | FL | 33126 |
| K150578 | Capillus, LLC |
1430 South Dixie Highway, Suite 304 | Coral Gables | FL | 33146 |
| K143199 | Capillus, LLC |
1430 South Dixie Highway, Suite 304 | Coral Gables | FL | 33146 |
| K163170 | CAPILLUS, LLC |
1715 NW 82nd Avenue | MIAMI | FL | 33126 |
| K153618 | CAPILLUS, LLC |
1715 NW 82nd AVE | MIAMI | FL | 33126 |
| K160285 | CAPILLUS, LLC |
1715 NW 82nd AVE | MIAMI | FL | 33126 |
| K162994 | CAPILLUS, LLC |
1715 NW 82nd AVE | MIAMI | FL | 33126 |
| K151516 | Capillus, LLC |
1715 NW 82ND AVENUE | MIAMI | FL | 33126 |
| K171835 | Chongqing Peninsula Medical Technology Co., Ltd. |
No.2-4, 2F BLK1, Biological and Biochemical Park | Jiulongpo District | 404100 | |
| K192552 | Chongqing Peninsula Medical Technology Co., Ltd. |
No.2-4, 2F BLK1, Biological and Biochemical Park, | Jiulongpo District | 404100 | |
| K193667 | Conversion Labs, PR, LLC |
53 Calle Las Palmeras, Suite 802 | San Juan | PR | 00901 |
| K173678 | Cosmo Far East Technology Limited |
Room 1504, Building 1, XingJiJia Yuan, Bao'an Avenue | Shenzhen | 518000 | |
| K152587 | DERMASCALP LLC |
1700 ALMA DR SUITE 400 | PLANO | TX | 75075 |
| K173846 | DermaScalp LLC |
190 E. Stacy Rd | Allen | TX | 75002 |
| K250308 | Dongguan Boyuan Intelligent Technology Co., Ltd. |
Room 801, Building 3, No.3 Kuiqiao Road, | Dongguan | 523719 | |
| K210169 | Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd |
401, Building 1, #3, Xinxing 3rd Road, jiaoshe, Dongkeng | Dongguan | 523586 | |
| K222477 | Dongguan Lescolton Medical Equipment Co., Ltd |
402, Building 1, #3, Xinxing 3rd Road, jiaoshe, Dongkeng | Dongguan | 523443 | |
| K240472 | Dongguan Tutamen Metalwork Co., Ltd |
No.3, Huangguotang Road | DongGuan | 523000 | |
| K173843 | EGlobal, LLC |
10115 E Bell Rd | Scottsdale | AZ | 85260 |
| K162071 | EGLOBAL, LLC |
10115 E BELL RD STE 107 | SCOTTSDALE | AZ | 85260 |
| K242747 | Foreo Inc. |
1525 E Pama Lane | Las Vegas | NV | 89119 |
| K213094 | Freedom Laser Therapy, Inc. |
16782 Von Karman Avenue, Unit 15 | Irvine | CA | 92606 |
| K222081 | Freedom Laser Therapy, Inc. |
16782 Von Karman Avenue, Unit 15 | Irvine | CA | 92606 |
| K151662 | Freedom Laser Therapy, Inc. |
7815 Beverly Blvd., 3rd Floor | Los Angeles | CA | 90036 |
| K183417 | Freedom Laser Therapy, Inc. |
16782 Von Karman Avenue, Unit #15 | Irvine | CA | 92606 |
| K142824 | Hairlabs International Inc |
742 Harpeth Knoll Road | Nashville | TN | 37221 |
| K232356 | Hubei YJT Technology Co.,Ltd |
Room1-4 ,8F,Block7,Guannan Fuxing Pharmaceutical Park,No.62 | Wuhan | 430000 | |
| K230134 | Hubei YJT Technology Co.,Ltd |
Room 1-8,8F, Building 7, Guannan Fuxing Pharmacel Park, | Wuhan | 43000 | |
| K213027 | Kam Yuen Plastic Products Ltd |
No. 2, Heng Feng Two Road, Pu Jin Industrial, Konghou Town | ZhongShan | 528400 | |
| K213025 | Kam Yuen Plastic Products Ltd. |
No. 2, Hengfeng 2nd Road, Pujin Industrial, Konghou Town | Zhongshan | 528400 | |
| K181878 | Kiierr International, LLC |
863 East Downington Avenue | Salt Lake City | UT | 84105-3211 |
| K191754 | Kunshan Bella Optical technology Co., Ltd. |
Plant 2, Kunshan Development Zone, | Kunshan | 215300 | |
| K211192 | Leana Orders, Inc |
12 Jefferson Boulevard, Suite 1F | Staten Island | NY | 10312 |
| K171895 | Leana Orders, Inc. |
431 Travis Avenue | Staten Island | NY | 10314-6150 |
| K111714 | LEXINGTON INTERNATIONAL, LLC |
1400 SIXTEENTH STREET, NW | WASHINGTON | DC | 20036 |
| K180885 | Lexington International, LLC |
1040 Holland Drive | Boca Raton | FL | 33487 |
| K103368 | LEXINGTON INTERNATIONAL, LLC |
1400 SIXTEENTH STREET, NW | WASHINGTON | DC | 20036 |
| K110233 | LEXINGTON INTERNATIONAL, LLC |
1400 SIXTEENTH STREET, NW | WASHINGTON | DC | 20036 |
| K060305 | LEXINGTON INTERNATIONAL, LLC |
1700 PENNSYLVANIA AVENUE, NW | WASHINGTON | DC | 20006 |
| K112524 | LEXINGTON INTERNATIONAL, LLC |
777 YAMATO RD., SUITE 105 | BOCA RATON | FL | 33431 |
| K093499 | LEXINGTON INTERNATIONAL, LLC |
901 KING STREET, SUITE 200 | ALEXANDRIA | VA | 22314 |
| K142573 | LEXINGTON INTERNATIONAL, LLC |
777 YAMATO RD SUITE 105 | BOCA RATON | FL | 33431 |
| K200464 | LG Electronics, Inc. |
222 LG-ro Jinwi-myeon | Pyeongtaek-si | 17709 | |
| K230597 | Light Tree Ventures Europe B.V. |
40A Fuxin Road, Fuyong Subdistrict, BaoAn District | Hague | ||
| K230336 | Light Tree Ventures Europe B.V. |
Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands | Hague | ||
| K222790 | Lumenis Be, Ltd. |
6 Hakidma Street PO BOX 240 | Yokneam | 2069204 | |
| K091496 | MIDWEST R.F. LLC. |
1050 WALNUT RIDGE DRIVE | HARTLAND | WI | 53029 |
| K201854 | Nature Incredible Inc |
3422 Old Capitol Trail #569 | Wilmington | DE | 19808 |
| K231153 | Nature Incredible Inc |
3422 Old Capitol Trail #569 | Wilmington | DE | 19808 |
| K160728 | NUTRA LUXE MD LLC |
12801 COMMONWEALTH DR. UNIT 2-6 | FORT MYERS | FL | 33976 |
| K141588 | NUTRA LUXE MD, LLC |
5575 SANTA ROSA CT. | SPARKS | NV | 89436 |
| K141596 | NUTRA LUXE MD, LLC |
5575 SANTA ROSA CT. | SPARKS | NV | 89436 |
| K183329 | OMM Imports, Inc. D/B/A Zero Gravity |
1945 S Ocean Dr Apt 509 Hallandale Beach Blvd | Hallandale | FL | 33009 |
| K173729 | PhotonMD, Inc |
627 Davis Drive, Suite 400 | Morrisville | NC | 27560 |
| K181253 | PJM Worldwide, LLC d/b/a Phoenix Medical Technology, LLC |
1499 NW 79th Avenue | Miami | FL | 33126 |
| K192585 | PJM Worldwide, LLC d/b/a Phoenix Medical Technology, LLC |
1499 NW 79th Avenue | Miami | FL | 33126 |
| K240456 | PLM Worldwide, LLC d/b/a Phoenix Medical Technology, LLC |
1499 NW 79th Ave | Miami | FL | 33126 |
| K182501 | Pulsaderm LLC |
12801 Commonwealth Dr. Units 2-6 | Fort Myers | FL | 33913 |
| K242441 | Revian, Inc. |
615 Davis Drive | Morrisville | NC | 27560 |
| K192627 | Shang Fa Biotechnology Co. |
B1F., No. 6, Ln. 1, Qingli St., Tucheng Dist., | New Taipei City | 23677 | |
| K242620 | Shenzhen Breo Technology Co., Ltd. |
19/F Hisense Southen Building No.1777 | Shenzhen | 518054 | |
| K213447 | Shenzhen CosBeauty Technology Co., Ltd. |
UnitA-3F, Qiao De Industrial Park, | Shenzhen | 518000 | |
| K250467 | Shenzhen Idea Light Limited |
3rd Floor, Block B, Shengdelan Industry Park, | Shenzhen | 518110 | |
| K251017 | Shenzhen Kaiyan Medical Equipment Co., Ltd |
Building#3 and Building#5, 40th of Fuxin Street | Shenzhen | 518103 | |
| K242363 | Shenzhen Kaiyan Medical Equipment Co., Ltd |
Building#3 and Building #5, 40th of Fuxin Street, | Shenzhen | 518103 | |
| K231321 | Shenzhen Kaiyan Medical Equipment Co., Ltd |
Building#3 and Building#5, 40th of Fuxin Street | Shenzhen | 518103 | |
| K241342 | Shenzhen Nuon Medical Equipment Co., Ltd |
1F-3F, No.27-2, Xintang Rd, Xintian Comm, Fuhai Str, | Shenzhen | 518000 | |
| K190467 | Slinph Technologies Co., LTD |
Room 211, Building B, 1970 Cultural and Creative Industrial | Shenzhen | 518107 | |
| K162782 | Slinph Technologies Co., LTD |
Room 211, Building B, 1970 Cultural and Creative Park, | Shenzhen | 518107 | |
| K202631 | Slinph Technologies Co., Ltd |
Room 211, Building B, | Longhua, Shenzhen | 518110 | |
| K121920 | SUNETICS INTERNATIONAL MARKETING GROUP, LLC |
892 STEGER TOWNE RD #44 | ROCKWALL | TX | 75032 |
| K132646 | SUNETICS INTERNATIONAL MARKETING GROUP, LLC |
892 STEGER TOWNE RD #44 | ROCKWALL | TX | 75032 |
| K172982 | Super Grow Lasers |
1903 Commonwealth Street #16 | Houston | TX | 77006 |
| K181308 | Super Grow Lasers |
1903 Commonwealth Street #16 | Houston | TX | 77006 |
| K240689 | Telebrands Corporation |
One Telebrands Plaza | Fairfield | NJ | 07004 |
| K113097 | THERADOME INC. |
1001 BEAR ISLAND RD, | SUMMERVILLE | SC | 29483 |
| K122950 | THERADOME INC. |
4900 HOPYARD ROAD | PLEASANTON | CA | 94588 |
| K171775 | Theradome Inc. |
4900 Hopyard Rd, Ste 100 | Pleasanton | CA | 94588 |
| K161046 | Theradome, Inc |
4900 Hopyard Road, Suite 100 | Pleasanton | CA | 94588 |
| K180460 | Theradome, Inc. |
4900 Hopyard Road, Suite 100 | Pleasanton | CA | 94588 |
| K203826 | Transdermal Cap, Inc. |
26 Alpha Park | Highland Heights | OH | 44143 |
| K150613 | TRANSDERMAL CAP, INC. |
3615 SUPERIOR AVENUE, SUITE 3104F | CLEVELAND | OH | 44114 |
| K161875 | TRANSDERMAL CAP, INC. |
938 CHESTNUT RUN | GATES MILLS | OH | 44040 |
| K152019 | TROPHY SKIN, INC. |
4372 KENMORE TRAIL | FRISCO | TX | 75034 |
| K192425 | Won Tech Co., Ltd. |
64 Techno 8-Ro, Yuseong-gu | Daejeon | 34028 | |
| K223862 | Won Tech Co., Ltd. |
64 Techno 8-Ro, Yuseong-gu | Daejeon | 34028 | |
| K240064 | Won Tech Co., Ltd. |
64 Techno8-ro, Yuseong-gu | Daejeon | 34028 | |
| K182562 | WonTech |
64 Techno 8-ro, Yuseong-gu | Daejeon | 305-500 | |
| K191154 | Wontech |
64 Techno 8-ro, Yuseong-gu | Daejeon | 305-500 | |
| K222364 | Xtrallux, LLC |
7260 NW 58th Street | Miami | FL | 33166 |
| K190685 | Xuzhou Kernel Medical Equipment Co., Ltd. |
Kernel Mansion, Economic Development District | Xuzhou | ||
| K200929 | Xuzhou Kernel Medical Equipment Co., Ltd. |
Kernel Mansion, Economic Development District | Xuzhou | ||
| K180617 | Y&J BIO Co, Ltd., |
No. C-413, Munjeong Hyundai Knowledge Center 1, | Seoul | 05836 | |
| K202983 | Y&J BIO Co., Ltd. |
B-916, 947, Hanam-daero | Hanam-si | 12982 | |
| K172968 | Y&J BIO Co., Ltd. |
No. C-413, Munjeong Hyundai Knowledge Center 1, 7 | Seoul | 05836 | |
| K213789 | Yibin Yingtong Intelligent Technology Co.,Ltd. |
3F, Building 1, Area A, Intelligent Terminal Industrial Park | Yibin | 644000 |
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