FDA certificate

FDA certificate

FDA certificate

Product catalog summary

Certificate Overview: This document is a Certificate to Foreign Government issued by the U.S. Food and Drug Administration (FDA) for medical devices manufactured by Beijing Sano Laser S&T Development Co, Ltd. in China. The certificate confirms that the devices listed are authorized for marketing in the United States and comply with the FDA's good manufacturing practice requirements.

Validity: The certificate is valid from June 11, 2026, to June 10, 2028.

Devices Listed:

  • Diode Laser Hair Removal System
  • HI-EMT MAGSHAPE
  • Cryojet Plus (SHE-ACP001-1)
  • CO2 Laser Therapy Systems (SHE-LSP003-1)
  • Q-Switched Nd:YAG Laser (SHE-LSP101-1)
  • LumiGlam Laser System (SHE-LSP601-3)

Manufacturer Details: The devices are manufactured by Beijing Sano Laser S&T Development Co, Ltd., located at Room 7-201, No.1, Caida 3rd Street, Nancai Town, Shunyi District, Beijing, China 101300.

Regulatory Compliance: The manufacturing site is subject to FDA jurisdiction under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and undergoes periodic inspections to ensure compliance with current good manufacturing practices.

Contact Information: The certificate is signed by CDR Cesar A. Perez, PhD, Director of the Division of Establishment Support, Office of Regulatory Programs, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, U.S. Food and Drug Administration.

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Catalog excerpts

FDA certificate-1

FDA U.S. FOOD & DRUG ADMINISTRATION U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov Certificate No. CFG-NE1844-6-2026-1 CERTIFICATE TO FOREIGN GOVERNMENT FOR DEVICE NOT EXPORTED FROM THE UNITED STATES The U.S. Food and Drug Administration (FDA) certifies the following information concerning the device(s) listed below to be shipped from CHINA into foreign countries. See Attached List Name of Manufacturer Beijing Sano Laser S&T Development Co, Ltd. (One Page) Room 7-201, No.1, Caida 3rd Street, Nancai Town, Shunyi District beijing, Beijing CHINA 101300 The device(s) described above (and the manufacturing site(s) which produces it) is subject to the jurisdiction of the FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act). It is certified that the above device(s) may be marketed in the United States of America at this time. The manufacturing establishment(s) in which the device(s) is produced is subject to periodic inspections.The last such inspection showed that the establishment(s), at that time, appeared to be in substantial compliance with current good manufacturing practice requirements for the device(s) listed above. CDR Cesar A. Perez, PhD, Director DRP2: Division of Establishment Support Office of Regulatory Programs Office of Product Evaluation and Quality Center for Devices and Radiological Health U.S. Food and Drug Administration, DHHS To verify the authenticity of the information on this certificate, you may scan the QR code or visit www.access.fda.gov/fecv/CDRH.

 Open the catalog to page 1
FDA certificate-2

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov Beijing Sano Laser S&T Development Co, Ltd. Room 7-201, No.1, Caida 3rd Street, Nancai Town, Shunyi District beijing, Beijing CHINA 101300 Diode Laser Hair Removal System HI-EMT MAGSHAPE Cryojet Plus (SHE-ACP001-1) Q-Switched Nd:YAG Laser (SHE-LSP101-1) LumiGlam Laser System (SHE-LSP601-3)

 Open the catalog to page 2

All Beijing Sanhe Beauty catalogs and technical brochures

  1. V-shaping

    17  Pages

  2. 360 Portable

    11  Pages

  3. Magshape 005

    6  Pages

  4. Magshape 004

    13  Pages

  5. HIDL-1800

    13  Pages

  6. HIDL-808

    16  Pages

  7. SP-3 2000PS

    16  Pages

  8. Patrix

    9  Pages

  9. PINXEL-V

    14  Pages

  10. ICOOL-3

    17  Pages

  11. 8D HIFU

    18  Pages

  12. Rollashape

    14  Pages

  13. Indeeplus-S

    14  Pages

  14. P808S

    16  Pages

  15. DPL Vertical

    6  Pages

  16. DPL-V

    14  Pages

  17. Portable DPL-P

    13  Pages

  18. SHR950B

    12  Pages

  19. SHR950S-2

    13  Pages

  20. Magshape

    15  Pages

  21. SP-4 2000PS

    18  Pages

*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.