FDA Registration
Active
🇺🇸 United States
ACUDERM, INC.
Reg #: 1035236
·
FEI: 1035236
·
Expires 2026
Products
7
Proprietary Names
8
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- ACUDERM, INC.
- Registration Number
- 1035236
- FEI Number
- 1035236
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 6555 Powerline Road, Suite 114
- City
- FORT LAUDERDALE
- State
- FL
- ZIP
- 33309
- Country
- US
Regulatory Submissions
- 510(k) Number
- K874024
Owner / Operator
- Firm Name
- ACUDERM, INC.
- Operator Number
- 1035236
- Address
- 6555 Powerline Road, Suite 114
- City
- Fort Lauderdale
- State
- FL
- Postal Code
- 33309
- Country
- US
- Correspondent
- CHARLES R YEH
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 1996-09-03 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 1996-09-03 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2007-12-12 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 1996-09-03 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2007-12-12 |
| Apparatus, Exhaust, Surgical | FYD | Class 2 | General, Plastic Surgery | No | 2007-12-12 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2007-12-12 |
Proprietary Names
ACU-PUNCH KIT
Acu-Punch
ACU-MICRO-NEEDLE
ACU-NEEDLE
Scissors
ACU-GUARD Non-Latex / Sterile Sleeve
ACU-EVAC
ACU-DISPO-CURETTE
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device