Sybaritic, Inc.
FDA Regulatory Profile
Sybaritic, Inc. has 0 FDA recalls, 11 inspections, 1 510(k) clearance and 1 compliance action on record.
- Latest inspection
- Oct 5, 2023 · NAI
- Latest 510(k)
- Jul 2, 2003
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 11 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Oct 5, 2023 | Bloomington, MN | Devices | No Action Indicated (NAI) | 2131125 |
| Sep 8, 2022 | Bloomington, MN | Devices | No Action Indicated (NAI) | 2131125 |
| Sep 16, 2021 | Bloomington, MN | Devices | No Action Indicated (NAI) | 2131125 |
| Jul 2, 2019 | Bloomington, MN | Devices | No Action Indicated (NAI) | 2131125 |
| Mar 7, 2018 | Bloomington, MN | Devices | Official Action Indicated (OAI) | 2131125 |
| Sep 7, 2016 | Bloomington, MN | Devices | No Action Indicated (NAI) | 2131125 |
| Aug 9, 2013 | Bloomington, MN | Devices | Voluntary Action Indicated (VAI) | 2131125 |
| Jun 29, 2012 | Bloomington, MN | Devices | Official Action Indicated (OAI) | 2131125 |
| Mar 5, 2010 | Bloomington, MN | Devices | Official Action Indicated (OAI) | 2131125 |
| Mar 30, 2009 | Bloomington, MN | Devices | Official Action Indicated (OAI) | 2131125 |
| Mar 18, 2009 | Bloomington, MN | Devices | Official Action Indicated (OAI) | 2131125 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 2131125 | Bloomington, MN | 11 | Oct 5, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K024307 | DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM | Jul 2, 2003 |