Advance-Esthetic LLC
4 extracted findings · 1 model-assigned issue type
FDA source excerpt, selected passage
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…
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Devices were marketed without required premarket approval or investigational device exemption, making them adulterated.
Supporting FDA text
Source excerpt · automated text-match checkour 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.
Devices were misbranded because the firm failed to submit required premarket notification under section 510(k).
Supporting FDA text
Source excerpt · automated text-match checkThe 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).
Devices exceeded exemption limitations by using radiofrequency and light-based technology, a different fundamental scientific technology.
Supporting FDA text
Source excerpt · automated text-match checkBecause 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.
Devices exceeded exemption limitations because their intended uses differ from those of legally marketed therapeutic massagers.
Supporting FDA text
Source excerpt · automated text-match checkBecause 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.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
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What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Provide specific steps taken to address the noted violations and an explanation of how the firm plans to prevent these violations or similar violations from occurring again.
- Include documentation of corrections and/or corrective actions that address systemic problems.
- Provide a timetable for implementation of planned corrections and corrective actions if they will occur over time.
- If corrections cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed.
- If the firm believes the products are not in violation, include reasoning and supporting information for consideration.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.