Data / Medical devices / United States / Crown Laboratories, Inc.
Crown Laboratories, Inc.: FDA-registered device maker in Johnson City, TN, United States, 4 510(k) clearances
Crown Laboratories, Inc. is registered with the FDA (registration 3012481754) in Johnson City, TN, United States. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 2, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3012481754
- FEI number
- 1019820
- Address
- 349 Lafe Cox Drive, Johnson City, TN, United States, 37604
- Owner or operator
- Crown Laboratories, Inc. (10051906)
- Roles
- Complaint file establishment, Contract manufacturer, Repackager or relabeler, Specification developer
- First device listed
- March 18, 2019
- Registered through
- 2027
- Brand names listed
- Boost 2+ Flex, Lift HG, MicroPen EVO, PanOxyl Antimicrobial Purifying Mist, PanOxyl PM Overnight Spot Patches, SkinPen Precision Elite, SkinPen Precision System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | 2 | Repackager or relabeler | accessdata.fda.gov |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Complaint file establishment | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Powered Microneedle Device | QAI | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| May 2, 2025 | K243457 | Nixall Antimicrobial Solutions Skin & Wound Hydrogel | FRO | Substantially Equivalent | Seriously Clean, Ltd. | accessdata.fda.gov |
| August 29, 2024 | K241400 | SkinPen Precision Elite System | QAI | Substantially Equivalent | Crown Aesthetics | accessdata.fda.gov |
| November 24, 2021 | K212558 | MicroPen EVO | QAI | Substantially Equivalent | Eclipse Medcorp, LLC | accessdata.fda.gov |
| March 1, 2018 | DEN160029 | SkinPen Precision System | QAI | Unknown | Bellus Medical, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Hydrophilic
- All makers of Powered Microneedle Device
- All makers of Blood Specimen Collection Convenience Kit (Excludes Hiv)
- All makers of Dressing, Wound, Drug
- All makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic
- All makers of Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Updated May 2, 2025. 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.