FDA-Device2023-06-07Class II
Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of moderate and severe wrinkles in the mid and lower face. Model #: Gen 4
Cytrellis Biosystems, Inc.
Hazard
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, and/or scarring.
Sold states
Nationwide
Affected count
89 units
Manufactured in
299 Washington St Ste C, N/A, Woburn, MA, United States
Products
Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of moderate and severe wrinkles in the mid and lower face. Model #: Gen 4
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1648-2023Don't want to check this manually?
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