Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Light Based Over-The-Counter Hair Removal
510(k) Number K261705
Device Name Hair Removal Device (R3C16-G Pro, R3C16-V Pro)
Applicant
Shenzhen Jianchao Intelligent Technology Co., Ltd.
Rm101, 201, 301, Bldg.25, #68 Hexiu W. Rd., Fuhai St., Baoan
Shenzhen,  CN 518107
Applicant Contact Renne Qin
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co., Ltd.
Rm. 1509, Jingting Bldg., Dongzhou Community, Guangming St.,
Shenzhen,  CN 518107
Correspondent Contact Renne Qin
Regulation Number878.4810
Classification Product Code
OHT  
Date Received05/22/2026
Decision Date 08/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-