Flawless Beauty and Skin

Selected passages from the FDA letter

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

Passage 1

the Relumins Premium Derma Pen (SKU: RL-DERMAPEN), Relumins Premium Derma Pen Plus (SKU: RLDERMAPENPLUS), Mesopower Pen (SKU: MS-POWERPEN), Relumins Branded 35 needle Dermastamper (SKU: RL-STAMPER-35), Relumins Branded 80 needle Dermastamper (SKU: RL-STAMPER-80), Relumins Branded 1200 needle Dermaroller 1.0 mm (SKU: RLDERMROLLER1200-1.00mm) and Relumins Branded 1200 needle Dermaroller 2.0 mm (SKU: RL-DERMROLLER1200-2.00mm), and the Relumins Intense Glow Beauty Care Tool (SKU: RL-BEAUTYTOOL) are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because, for each of the above listed devices, an approved application for premarket approval (PMA) is not in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), nor has an application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g) been approved.

Passage 2

The devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because, for each of the above listed devices, a notice or other information respecting the devices was not provided as required by section 510(k) of the Act, 21 U.S.C. § 360(k).

Passage 3

As of this date, our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2022.

Passage 4

Therefore, the listed devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).