1NEED Pro

CAMPOMATS SRL · Model ASCAMPOMATS_1NEED_MN_PRO · UDI-DI 08055598060068

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510(k) clearances

Adverse events

Recalls

Facilities

Description

Microneedling device. 1NEED Pro consists of Handpiece Holder - Power Supply with detachable cable - Instructions for Use

Recalls

Date	Firm	Reason
2023-06-23	Cytrellis Biosystems, Inc.	Potential failure of a bearing adhesive joint that can occur due to an assembly issue of the X/Y stage of the handpiece. If a broken glue bond were to occur, it could cause an over
2023-04-07	Cytrellis Biosystems, Inc.	Irregular core patterns could cause potential overlap of cores at the 8% setting, potentially leading to prolonged healing, irregularities in patient skin texture post-treatment, a
2019-01-18	Bellus Medical	Cosmetic Kit was packaged with a mislabel medical product.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.