Data / Medical devices / United States / Cytrellis Biosystems, Inc.
Cytrellis Biosystems, Inc.: FDA-registered device maker in Woburn, MA, United States, 1 510(k) clearance
Cytrellis Biosystems, Inc. is registered with the FDA (registration 3020704367) in Woburn, MA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 9, 2021. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020704367
- Address
- 34 Commerce Way, Woburn, MA, United States, 01801
- Owner or operator
- Cytrellis Biosystems, Inc. (10082569)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- August 16, 2021
- Registered through
- 2026
- Brand names listed
- Ellacor(R) System with Micro-Coring(TM) Technology
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Microneedle Device | QAI | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 9, 2021 | K202517 | Cytrellis Dermal Micro-Coring System | QAI | Substantially Equivalent | Cytrellis Biosystems, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 23, 2023 | 92689 | Class II | Ongoing | 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 ty | 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 | accessdata.fda.gov |
| April 7, 2023 | 92187 | Class II | Completed | 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 | 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. | accessdata.fda.gov |
Compare with other makers
Updated August 11, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.