Skip to the page

Data / Medical devices / Laser, Comb, Hair

Laser, Comb, Hair (OAP): 58 FDA-registered makers in 13 countries

58 establishments in 13 countries are registered with the FDA to make Laser, Comb, Hair (product code OAP, Class 2, 21 CFR 890.5500). 42 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 115 510(k) clearances under this code, the latest on October 9, 2026, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
OAP
Device class
2
Regulation
890.5500
Medical specialty
Physical Medicine

Makers by country

CountryMakers
China26
United States11
Hong Kong5
South Korea3
United Kingdom2
Israel2
Taiwan2
Italy2
India1
Netherlands1
Mexico1
France1
Malaysia1

Makers of Laser, Comb, Hair

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Curallux, LLCMiami, FL, United StatesComplaint file establishment, Manufacturer7September 12, 2019000api.fda.gov
Hairmax International LLCBoca Raton, FL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer6May 12, 2022000api.fda.gov
Cosmo Far East Technology LimitedShenzhen Guangdong, ChinaExporter to the US, Manufacturer5October 22, 2025000api.fda.gov
WONTECH Co., Ltd.Daejeon, South KoreaManufacturer5February 7, 2024000api.fda.gov
Apira Science, Inc.Albuquerque, NM, United StatesManufacturer4December 2, 2024000api.fda.gov
Remax Medi-Tech(shenzhen) CorporationShenzhen Guangdong, ChinaManufacturer4October 13, 2022000api.fda.gov
Dikaku Industrial Co.,limitedHong Kong, ChinaExporter to the US, Foreign private label distributor, Manufacturer3June 3, 2020000api.fda.gov
Hubei Yjt Intelligent Technology Group Co., Ltd.Wuhan Hubei, ChinaComplaint file establishment, Manufacturer3June 16, 2026000api.fda.gov
Light Tree Technology India Private LimitedGurugram Haryana, IndiaManufacturer3December 24, 2025000api.fda.gov
PJM Worldwide, LLCMiami, FL, United StatesRepackager or relabeler, Specification developer3May 22, 2024000api.fda.gov
Slinph Technologies Co., LtdChangsha Hunan, ChinaComplaint file establishment, Exporter to the US, Manufacturer, Repackager or relabeler3December 8, 2020000api.fda.gov
Shenzhen Kaiyan Medical Equipment Co., LtdShenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer3January 23, 2026000api.fda.gov
Shenzhen Lescolton Medical Equipment Co., Ltd.shenzhen Guangdong, ChinaManufacturer3May 23, 2023000api.fda.gov
Chongqing Peninsula Medical Technology Co., Ltd.Chongqing, ChinaComplaint file establishment, Foreign private label distributor, Manufacturer, Repackager or relabeler2April 17, 2020000api.fda.gov
Kam Yuen Plastic Products Ltd.zhongshan Guangdong, ChinaManufacturer2May 26, 2022000api.fda.gov
Light Tree Ventures Europe B.V.'S-Gravenhage Zuid-Holland, NetherlandsComplaint file establishment, Manufacturer2December 24, 2025000api.fda.gov
REVIAN, IncMorrisville, NC, United StatesComplaint file establishment, Specification developer2September 13, 2024000api.fda.gov
Theradome, Inc.Wilmington, DE, United StatesSpecification developer2May 12, 2016000api.fda.gov
Tutamen De Mexico, LLCTijuana Baja California, MexicoManufacturer2September 13, 2024000api.fda.gov
The Beauty Tech Group LtdMacclesfield Cheshire East, United KingdomExporter to the US, Specification developer2June 17, 2025000api.fda.gov
Xtrallux, LLCMiami, FL, United StatesComplaint file establishment, Manufacturer2May 23, 2023000api.fda.gov
Xuzhou Kernel Medical Equipment Co LtdXuzhou Jiangsu, ChinaManufacturer2June 3, 2020000api.fda.gov
Y&j Bio Co., Ltd.Hanam-si Gyeonggi, South KoreaManufacturer2December 8, 2020000api.fda.gov
Alma Lasers Ltd.CAESAREA Northern, IsraelManufacturer1June 5, 2026000api.fda.gov
Biophotas, Inc.Tustin, CA, United StatesComplaint file establishment, Manufacturer1June 29, 2021000api.fda.gov
Bella Medical Technology (Suzhou) Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Manufacturer1November 22, 2019000api.fda.gov
China 1 Link, LtdMongkok Kowloon, Hong KongExporter to the US, Specification developer1January 16, 2019000api.fda.gov
Dongguan Boyuan Intelligent Technology Co., LtdDONGGUAN CITY Guangdong, ChinaManufacturer1April 29, 2025000api.fda.gov
Dongguan Tutamen Metalwork Co.,LTD.Dongguan Guangdong, ChinaExporter to the US, Manufacturer1October 11, 2024000api.fda.gov
Gooten Innolife CorporationTaichung City, TaiwanContract manufacturer, Exporter to the US1November 23, 2009000api.fda.gov
Hair Laser Manufacturing, LLCSouthlake, TX, United StatesManufacturer1December 20, 2013000api.fda.gov
Lumenis Be LtdYokneam, Ha Zafon 2069236 Haifa, IsraelManufacturer, Specification developer1June 14, 2023000api.fda.gov
Opatra LtdLondon London, City of, United KingdomManufacturer1April 28, 2023000api.fda.gov
Shang Far Biotechnology Co.New Taipei City, TaiwanManufacturer1December 13, 2019000api.fda.gov
Shenzhen Idea Light LimitedShenzhen Guangdong, ChinaExporter to the US, Manufacturer1June 5, 2025000api.fda.gov
Shenzhen Willcareyou Technology Co., LtdShenzhen Guangdong, ChinaManufacturer1December 13, 2019000api.fda.gov
Shenzhen Breo Technology Co., LtdSHENZHEN Guangdong, ChinaManufacturer1November 1, 2024000api.fda.gov
TRANSDERMAL CAP INC dba LaserCap CompanyHighland Heights, OH, United StatesManufacturer1March 29, 2021000api.fda.gov
Vis (shanghai) Technology Co., Ltd.Jinshan District Shanghai, ChinaManufacturer1December 11, 2024000api.fda.gov
Wiser LivingSeoul, South KoreaManufacturer1September 30, 2019000api.fda.gov
Zdeer Technology (henan) Co., LtdXuchang City Henan, ChinaExporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler1June 16, 2026000api.fda.gov
Ziree (Shenzhen) Medical Technology Co.,LtdShenzhen Guangdong, ChinaManufacturer1June 26, 2026000api.fda.gov
Espansione Marketing SPAFUNO Bologna, ItalyManufacturer0000api.fda.gov
Espansione Marketing SPACREVALCORE Bologna, ItalyManufacturer0000api.fda.gov
Gorgeous Beauty Equipment Manufacture LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
Guangdong Fuqiang Beauty Equipment Co.,limitedQingyuan Guangdong, ChinaManufacturer0000api.fda.gov
Guangzhou Niansheng Beauty Equipment Co., Ltd.Guangzhou Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hebei Mita Biotechnology LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
Hebei Mita Technology LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
Hebei Tuosite Technology Co.,ltdShijiazhuang Hebei, ChinaManufacturer0000api.fda.gov
Modulus Inc.Milpitas, CA, United StatesContract manufacturer0000api.fda.gov
NooancePARIS Ile-de-France, FranceContract manufacturer0000api.fda.gov
Oman Medical Beauty Manufacture LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
Opulent Solutions SDN.BHD.Bayan Lepas Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Shenzhen Allbeauty Technology Co., LtdShenzhen City Guangdong, ChinaContract manufacturer0000api.fda.gov
Shenzhen Jie Zhong Lian Technology Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Touchbeauty Beauty & Health (shenzhen) Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Zhejiang Runqiang Medical Instruments Co.,ltd.Jiaxing Zhejiang, ChinaContract manufacturer0000api.fda.gov

Updated October 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.