FDA Registration
Active
🇺🇸 United States
CROWN LABORATORIES, INC.
Reg #: 3012481754
·
FEI: 1019820
·
Expires 2026
Products
6
Proprietary Names
7
Establishment Types
4
Classifications
6
Registration Details
- Registration Name
- CROWN LABORATORIES, INC.
- Registration Number
- 3012481754
- FEI Number
- 1019820
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 349 Lafe Cox Drive
- City
- Johnson City
- State
- TN
- ZIP
- 37604
- Country
- US
Regulatory Submissions
- 510(k) Number
- K241400
Owner / Operator
- Firm Name
- Crown Laboratories, Inc.
- Operator Number
- 10051906
- Address
- 349 Lafe Cox Drive
- City
- Johnson City
- State
- TN
- Postal Code
- 37604
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2019-03-19 |
| Powered Microneedle Device | QAI | Class 2 | General, Plastic Surgery | No | 2024-10-16 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2019-06-07 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2020-01-20 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2025-12-11 |
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | Class 2 | Clinical Chemistry | No | 2022-03-21 |
Proprietary Names
Boost 2+ Flex
SkinPen Precision Elite
SkinPen Precision System
Lift HG
PanOxyl PM Overnight Spot Patches
PanOxyl Antimicrobial Purifying Mist
MicroPen EVO
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility