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Crown Aesthetics

3 FDA records filed under this company name, from 2021 to 2024, in microneedling (prescription) (QAI, 3).

The applicant is the company that filed with FDA. It can be the brand you know or a manufacturer that makes devices sold under other brand names; the device name as filed often shows which. We don't merge different company names, so check the A–Z list for related entries.

Powered microneedling devices (prescription) (QAI, 3)

510(k) cleared

SkinPen Precision Elite System

510(k) number
K241400
Applicant
Crown Aesthetics
Product code
QAI: Powered Microneedle Device (prescription device code)
Regulation
21 CFR 878.4430, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The SkinPen® Precision Elite System is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older.”

Copied from the text of FDA's 510(k) document (PDF, page 5), with line breaks removed.

510(k) cleared

SkinPen Precision System

510(k) number
K220506
Applicant
Crown Aesthetics
Product code
QAI: Powered Microneedle Device (prescription device code)
Regulation
21 CFR 878.4430, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 3.

510(k) cleared

SkinPen Precision System

510(k) number
K202243
Applicant
Crown Aesthetics
Product code
QAI: Powered Microneedle Device (prescription device code)
Regulation
21 CFR 878.4430, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The SkinPen® Precision system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.