Advance-Esthetic LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

our inspection revealed that the Zemits CrystalFrax Pro, Zemits Abigon Pro and Zemits Bionexis Lite Pro 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed.

Passage 2

The Zemits CrystalFrax Pro, Zemits Abigon Pro, and Zemits Bionexis Lite Pro are also misbranded under section 502(o) of 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).

Passage 3

Because your devices operate using a different fundamental scientific technology than legally marketed devices in the generic type of devices of therapeutic massagers regulated under 21 CFR 890.5660, these devices exceed the limitations described in 21 CFR 890.9(b) and are not exempt from premarket notification requirements.

Passage 4

Because your devices are for different intended uses than legally marketed devices in that generic type of devices of therapeutic massagers regulated under 890.5660, the devices exceed the limitations described in 21 CFR 890.9(a) and are not exempt from premarket notification requirements.