510(k) Report

FDA applicant

Crown Aesthetics

Dallas, TX3 decisions2021–20240 recalls

FDA records 3 decisions for Crown Aesthetics (Dallas, TX) from 2021 to 2024: 3 510(k) clearances. All are in product code QAI (Powered Microneedle Device). Since 2016 its 510(k)s took a median of 104 days from receipt to decision, against 172 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Crown Aesthetics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2021: 12022: 12024: 1
2021high 1 (2021) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Crown Aesthetics by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Crown Aesthetics’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • QAIPowered Microneedle Device3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 104 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 172 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K220506SkinPen Precision SystemCrown Aesthetics · 20222cite it
  • K202243SkinPen Precision SystemCrown Aesthetics · 20212cite it

What has FDA decided for it lately?

  • K241400SkinPen Precision Elite SystemCrown Aesthetics · 2024
  • K220506SkinPen Precision SystemCrown Aesthetics · 2022
  • K202243SkinPen Precision SystemCrown Aesthetics · 2021

All 3 as Crown Aesthetics →

Other applicant names beginning “Crown”

FDA records each applicant name separately; these may or may not be the same firm.

Crown Delta Corp. 18Crown Name Disposable Hygiene Products Fty., Ltd. 2Crown Porcelain Dental Technology Co., Ltd. 1