Home Laser Systems With NO Clearance
Dec 2011 – Before you buy Venus or Epila IPL Laser Hair Removal System, you should read this. The FDA (Food and Drug Administration) has published a WARNING LETTER to the manufacturer of the Venus or Epila hair removal machine.
If a person is looking to find who is the manufacturer of the Venus or Epila home laser system it would be nearly impossible to locate “who stands behind the product”. Any Google search for the Venus or Epila system just generates (except Amazon and Youtube) lots of sales pages with duplicate material from worthless websites. Following the Youtube channel of MyEspil to the MyEspil.com results in a dead end. There seems to be no website to read information, find customer support, contact page.
BNB Medical Co. Ltd
Following some clues and deeper searches reveal that the Venus laser, Epila laser or Espil IPL Laser Hair Removal System BSL-10 is manufactured by BNB Medical Co., Ltd.
BNB Medical Co., Ltd is a Korean company here is the address: Room404, Hyundai Hyel, 779-11, Jayang-Dong Gwangjin-Ku, Seoul, South Korea. Tel:82 2 454 6406, Information by Email: email@example.com
The FDA Warning: BND Laser Hair Removal Devices
Below you can read part of the FDA warning sent to Korea BNB Medical Co., Ltd, it seems the manufacturer began to distribute two of the systems (Models W-808, CW-808 Epila and Venus Laser Hair Removal devices) without official clearance from the FDA.
“Dear Mr. Yoo:
The Food and Drug Administration (FDA) has learned that your firm is marketing the BND Laser Hair Removal devices, Models W-808, CW-808 also known as Epila and Venus Laser Hair Removal devices] in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), Epila and Venus Laser Hair Removal devices 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 are intended to affect the structure or function of the body.
The devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do 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 (IED) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by sections 510(k) of the Act, 21 U.S.C. 360(k).
Our records show that your section 510(k) application for the above-mentioned device requesting clearance for the device for Over-the-Counter use has not been given final clearance by the Office of Device Evaluation (ODE). In a letter dated August 19, 2010, ODE’s advised you of this action and thus the 510(k) application remains on hold pending receipt of clinical data demonstrating that a lay person could read the directions for use and safely and effectively use the device. ” Read Source FDA Warning Letter.
Venus, Epila or Espil IPL Hair Removal Systems
It is somewhat troubling that a manufacturer receives a warning letter from the FDA, it does not mean the devices mentioned here are not safe. We currently can not even say if BNB Medical Co., Ltd replied with written response to this letter within 15 working days as requested.
What can be a problem is buying a system with a website that is nearly impossible to be found on the web. The BNB Medical Co., Ltd has a website, with full English information, but it is not located or easily found. You can learn more about Venus laser or Epila laser and Espil IPL Laser Hair Removal System BSL-10 HERE.
Read More Related Posts:
- Which Home laser Systems Are FDA Approved
- The Difference Between Permanent Removal Vs. Permanent Reduction
- Risk For Skin Cancer After Laser or IPL Hair Removal
- Silk’n SensEpil Vs ‘Me my Elos’ Comparison
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