FDA-Device2023-08-16Class II
ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. Model #: Gen 4
Cytrellis Biosystems, Inc.
Hazard
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 overlap of cores, potentially leading to prolonged healing and irregularities in patient skin texture post-treatment, and/or scarring
Sold states
Nationwide
Affected count
127 systems
Manufactured in
299 Washington St Ste C, N/A, Woburn, MA, United States
Products
ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. Model #: Gen 4
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2393-2023Don't want to check this manually?
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