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
| Country | Makers |
|---|---|
| China | 26 |
| United States | 11 |
| Hong Kong | 5 |
| South Korea | 3 |
| United Kingdom | 2 |
| Israel | 2 |
| Taiwan | 2 |
| Italy | 2 |
| India | 1 |
| Netherlands | 1 |
| Mexico | 1 |
| France | 1 |
| Malaysia | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Curallux, LLC | Miami, FL, United States | Complaint file establishment, Manufacturer | 7 | September 12, 2019 | 0 | 0 | 0 | api.fda.gov |
| Hairmax International LLC | Boca Raton, FL, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 6 | May 12, 2022 | 0 | 0 | 0 | api.fda.gov |
| Cosmo Far East Technology Limited | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 5 | October 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| WONTECH Co., Ltd. | Daejeon, South Korea | Manufacturer | 5 | February 7, 2024 | 0 | 0 | 0 | api.fda.gov |
| Apira Science, Inc. | Albuquerque, NM, United States | Manufacturer | 4 | December 2, 2024 | 0 | 0 | 0 | api.fda.gov |
| Remax Medi-Tech(shenzhen) Corporation | Shenzhen Guangdong, China | Manufacturer | 4 | October 13, 2022 | 0 | 0 | 0 | api.fda.gov |
| Dikaku Industrial Co.,limited | Hong Kong, China | Exporter to the US, Foreign private label distributor, Manufacturer | 3 | June 3, 2020 | 0 | 0 | 0 | api.fda.gov |
| Hubei Yjt Intelligent Technology Group Co., Ltd. | Wuhan Hubei, China | Complaint file establishment, Manufacturer | 3 | June 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| Light Tree Technology India Private Limited | Gurugram Haryana, India | Manufacturer | 3 | December 24, 2025 | 0 | 0 | 0 | api.fda.gov |
| PJM Worldwide, LLC | Miami, FL, United States | Repackager or relabeler, Specification developer | 3 | May 22, 2024 | 0 | 0 | 0 | api.fda.gov |
| Slinph Technologies Co., Ltd | Changsha Hunan, China | Complaint file establishment, Exporter to the US, Manufacturer, Repackager or relabeler | 3 | December 8, 2020 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Kaiyan Medical Equipment Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 3 | January 23, 2026 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Lescolton Medical Equipment Co., Ltd. | shenzhen Guangdong, China | Manufacturer | 3 | May 23, 2023 | 0 | 0 | 0 | api.fda.gov |
| Chongqing Peninsula Medical Technology Co., Ltd. | Chongqing, China | Complaint file establishment, Foreign private label distributor, Manufacturer, Repackager or relabeler | 2 | April 17, 2020 | 0 | 0 | 0 | api.fda.gov |
| Kam Yuen Plastic Products Ltd. | zhongshan Guangdong, China | Manufacturer | 2 | May 26, 2022 | 0 | 0 | 0 | api.fda.gov |
| Light Tree Ventures Europe B.V. | 'S-Gravenhage Zuid-Holland, Netherlands | Complaint file establishment, Manufacturer | 2 | December 24, 2025 | 0 | 0 | 0 | api.fda.gov |
| REVIAN, Inc | Morrisville, NC, United States | Complaint file establishment, Specification developer | 2 | September 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| Theradome, Inc. | Wilmington, DE, United States | Specification developer | 2 | May 12, 2016 | 0 | 0 | 0 | api.fda.gov |
| Tutamen De Mexico, LLC | Tijuana Baja California, Mexico | Manufacturer | 2 | September 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| The Beauty Tech Group Ltd | Macclesfield Cheshire East, United Kingdom | Exporter to the US, Specification developer | 2 | June 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Xtrallux, LLC | Miami, FL, United States | Complaint file establishment, Manufacturer | 2 | May 23, 2023 | 0 | 0 | 0 | api.fda.gov |
| Xuzhou Kernel Medical Equipment Co Ltd | Xuzhou Jiangsu, China | Manufacturer | 2 | June 3, 2020 | 0 | 0 | 0 | api.fda.gov |
| Y&j Bio Co., Ltd. | Hanam-si Gyeonggi, South Korea | Manufacturer | 2 | December 8, 2020 | 0 | 0 | 0 | api.fda.gov |
| Alma Lasers Ltd. | CAESAREA Northern, Israel | Manufacturer | 1 | June 5, 2026 | 0 | 0 | 0 | api.fda.gov |
| Biophotas, Inc. | Tustin, CA, United States | Complaint file establishment, Manufacturer | 1 | June 29, 2021 | 0 | 0 | 0 | api.fda.gov |
| Bella Medical Technology (Suzhou) Co., Ltd. | Suzhou Jiangsu, China | Exporter to the US, Manufacturer | 1 | November 22, 2019 | 0 | 0 | 0 | api.fda.gov |
| China 1 Link, Ltd | Mongkok Kowloon, Hong Kong | Exporter to the US, Specification developer | 1 | January 16, 2019 | 0 | 0 | 0 | api.fda.gov |
| Dongguan Boyuan Intelligent Technology Co., Ltd | DONGGUAN CITY Guangdong, China | Manufacturer | 1 | April 29, 2025 | 0 | 0 | 0 | api.fda.gov |
| Dongguan Tutamen Metalwork Co.,LTD. | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 1 | October 11, 2024 | 0 | 0 | 0 | api.fda.gov |
| Gooten Innolife Corporation | Taichung City, Taiwan | Contract manufacturer, Exporter to the US | 1 | November 23, 2009 | 0 | 0 | 0 | api.fda.gov |
| Hair Laser Manufacturing, LLC | Southlake, TX, United States | Manufacturer | 1 | December 20, 2013 | 0 | 0 | 0 | api.fda.gov |
| Lumenis Be Ltd | Yokneam, Ha Zafon 2069236 Haifa, Israel | Manufacturer, Specification developer | 1 | June 14, 2023 | 0 | 0 | 0 | api.fda.gov |
| Opatra Ltd | London London, City of, United Kingdom | Manufacturer | 1 | April 28, 2023 | 0 | 0 | 0 | api.fda.gov |
| Shang Far Biotechnology Co. | New Taipei City, Taiwan | Manufacturer | 1 | December 13, 2019 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Idea Light Limited | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 1 | June 5, 2025 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Willcareyou Technology Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 1 | December 13, 2019 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Breo Technology Co., Ltd | SHENZHEN Guangdong, China | Manufacturer | 1 | November 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| TRANSDERMAL CAP INC dba LaserCap Company | Highland Heights, OH, United States | Manufacturer | 1 | March 29, 2021 | 0 | 0 | 0 | api.fda.gov |
| Vis (shanghai) Technology Co., Ltd. | Jinshan District Shanghai, China | Manufacturer | 1 | December 11, 2024 | 0 | 0 | 0 | api.fda.gov |
| Wiser Living | Seoul, South Korea | Manufacturer | 1 | September 30, 2019 | 0 | 0 | 0 | api.fda.gov |
| Zdeer Technology (henan) Co., Ltd | Xuchang City Henan, China | Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler | 1 | June 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| Ziree (Shenzhen) Medical Technology Co.,Ltd | Shenzhen Guangdong, China | Manufacturer | 1 | June 26, 2026 | 0 | 0 | 0 | api.fda.gov |
| Espansione Marketing SPA | FUNO Bologna, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Espansione Marketing SPA | CREVALCORE Bologna, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gorgeous Beauty Equipment Manufacture Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Fuqiang Beauty Equipment Co.,limited | Qingyuan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Niansheng Beauty Equipment Co., Ltd. | Guangzhou Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Mita Biotechnology Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Mita Technology Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Tuosite Technology Co.,ltd | Shijiazhuang Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modulus Inc. | Milpitas, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nooance | PARIS Ile-de-France, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oman Medical Beauty Manufacture Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Opulent Solutions SDN.BHD. | Bayan Lepas Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Allbeauty Technology Co., Ltd | Shenzhen City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Jie Zhong Lian Technology Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Touchbeauty Beauty & Health (shenzhen) Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Runqiang Medical Instruments Co.,ltd. | Jiaxing Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.