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Collagen P.I.N.

Induction Therapies, LLC · Model 1 · UDI-DI 00850021673055

QAI Prescription
1
510(k) clearances
59
Adverse events
3
Recalls
59
Facilities

Description

Microneedling Device Handpiece (Single)

Recalls

DateFirmReason
2023-06-23Cytrellis 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
2023-04-07Cytrellis 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
2019-01-18Bellus MedicalCosmetic 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.