Cytrellis Dermal Micro-Coring System— 510(k) K202517
Substantially EquivalentCytrellis Biosystems, Inc.
FDA 510(k) clearance K202517 for Cytrellis Dermal Micro-Coring System, Substantially Equivalent on 2021-07-09. Applicant: Cytrellis Biosystems, Inc.. Device class: 2.
Clearance details
- Applicant
- Cytrellis Biosystems, Inc.
- Product code
- Code QAI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4430
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Woburn, MA, US
Recent devices under product code QAI
view allRecalls naming K202517
K-number listed on FDA's recall record- Z-2393-2023 — 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
- Z-1648-2023 — 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
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K202517.
Data sourced from openFDA. This site is unofficial and independent of the FDA.