Aquavit Pharmaceuticals, Inc

Selected passages from the FDA letter

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

Passage 1

FDA has determined that the AQUAGOLD® *fine touch* and A.S.A.P! Micro Infusion System 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 approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.

Passage 2

The devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify FDA of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C.

Passage 3

Based on these claims, the AQUAGOLD® fine touch is a device because it is intended to deliver microdoses and microinjections of products into the skin for various medical purposes (e.g., stimulating collagen and elastin production, promoting wound healing, treating acne scars, hyperhidrosis, and alopecia).

Passage 4

Based on these claims, the A.S.A.P! Micro Infusion System is a device because it is intended to deliver micro-droplets of serums into the skin for various medical purposes (e.g., helping to regenerate damaged skin, reducing inflammation).

Passage 5

Based on the design and technology of these products, the entire microchannel is inserted into the skin and there is no mechanism that would prevent the user from inserting the entire microchannel into the skin. Therefore, your devices result in needle penetration beyond the stratum corneum and into the living layers of the skin (epidermis and dermis), showing that they are “intended to affect the structure or any function of the body” under section 201(h) of the FD&C Act.