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Mt. Derm GmbH

3 FDA records filed under this company name, from 2018 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

Exceed Unlimited

510(k) number
K233709
Applicant
Mt. Derm GmbH
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 4.

510(k) cleared

Exceed Microneedling device

510(k) number
K182407
Applicant
Mt. Derm GmbH
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 Exceed is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, III and IV in adults aged 22 years or older.”

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

510(k) cleared

Exceed Microneedling Device

510(k) number
K180778
Applicant
Mt. Derm GmbH
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 statement contains words we couldn't confirm (a typo, run-together words or a reading error), and we don't correct FDA's text. Read FDA's PDF, page 3.