FDA Registration
Active
🇺🇸 United States
EPL810 HP PURE Laser
Reg #: 3010761224
·
FEI: 3010761224
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ENDYMED MEDICAL INC.
- Registration Number
- 3010761224
- FEI Number
- 3010761224
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 4400 Route 9 South
- City
- East Freehold
- State
- NJ
- ZIP
- 07728
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222369
Owner / Operator
- Firm Name
- EndyMed Medical Inc.
- Operator Number
- 10046035
- Address
- 4400 Route 9 South
- City
- East Freehold
- State
- NJ
- Postal Code
- 07728
- Country
- US
- Correspondent
- Yoram Levy
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2022-11-06 |
Proprietary Names
EPL810 HP PURE Laser
Establishment Types
Repack or Relabel Medical Device