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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Lucky Beauty Equipment Co., LTD. 1/15/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
10903 New Hampshire Avenue
Silver Spring, MD 20993 

 

January 15, 2014
 
 
WARNING LETTER
 
VIA UNITED PARCEL SERVICE
 
Mr. Sun Jing
Lucky Beauty Equipment Co., LTD
1 # Daqiao North Road
Huaqiao Build, Room 2508
Nanjing, China
 
Re: Panda-B RF Beauty Device, Lipolaser Machine, LBS11 RF Skin Lift, LBS54 Lipo Laser Fat Burner, LBS56 Lipolaser and LBS12 Vertical RF
 
Refer to CMS # 417003
 
Dear Mr. Sun Jing:
 
The United States Food and Drug Administration (FDA) has learned that your firm is marketing the Panda-B RF Beauty Device, the Lipolaser Machine, the LBS11 RF Skin Lift, the LBS54 Lipo Laser Fat Burner, the LBS56 Lipolaser, and the LBS12 Vertical RF in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
 
Under section 201(h) of the Act, 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
 
The FDA has reviewed your firm’s website (www.luckybeauty.net), which revealed that your firm is marketing its devices with indications including, but not limited to, the following:
 
  • Panda-B RF Beauty Device for face lifting, tightening and sculpturing the waist, tightening and sculpturing the back, and lifting and tightening breasts;
  • Lipolaser Machine for intensive physical lipolysis to remove fat, cellulite reduction, and removing obstruction from channels and collaterals;
  • LBS11 RF Skin Lift Device for skin lifting and tightening skin, removing epidermis and deeper wrinkles, and stimulating the initial collagen cells;
  • LBS54 Lipo Laser Fat Burning Device for intensive physical lipolysis to remove fat, cellulite reduction, and promoting and accelerating the body’s metabolism;
  • Lbs56 Lipolaser for intensive physical lipolysis to remove fat and removing obstruction from channels and collaterals; and
  • LBS12 Vertical RF for skin lifting and tightening skin, body shaping, and stimulating collagen cells.

 

A review of our records has determined that your firm has not received premarket clearance and/or approval to market its devices in the United States, which is a violation of the law.  Therefore, the devices stated above are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g).  These devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). 
 
For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency.  21 CFR 807.81(b).  The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
 
Our office requests that Lucky Beauty Equipment Co., Ltd immediately cease activities that result in the misbranding or adulteration these devices, such as the commercial distribution of the devices for the uses discussed above.
 
Given the serious nature of the violations of the Act, the Panda-B RF Beauty device, the Lipolaser Machine, the LBS11 RF Skin Lift, the Lbs54 Lipo Laser Fat Burner, the Lbs56 Lipolaser, and the Lbs12 Vertical RF are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated.  As a result, FDA is taking steps to refuse entry of these devices into the United States, known as “detention without physical examination,” until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter. 
 
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrections and/or corrective actions (which must address systemic problems) your firm has taken.  If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities.  If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter. Please provide a translation of documentation not in English to facilitate our review.
 
Your firm’s response should be sent to:
 
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Field Inspections Support Branch
White Oak Building 66, Rm 2609
10903 New Hampshire Ave.
Silver Spring, MD 20993
 
Refer to the identification number CMS # 417003 when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: LaShanda M. Long, Chief, Surveillance Enforcement Branch I, Division of Premarket and Labeling Compliance, Office of Compliance, at (301) 796-5465 or via fax at (301) 847-8137.
 
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm.  It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by FDA. 
 
Sincerely yours,
/S/ 
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
    Radiological Health