FDA Registration
Active
🇩🇪 Germany
RevoLix and R Jr
Reg #: 3003168101
·
FEI: 3003168101
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- LISA LASER PRODUCTS GMBH
- Registration Number
- 3003168101
- FEI Number
- 3003168101
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ALBERT-EINSTEIN-STR. 4
- City
- KATLENBURG-LINDAU Lower Saxony
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K051167
Owner / Operator
- Firm Name
- OMNIGUIDE, INC.
- Operator Number
- 9070939
- Address
- 43 Manning Rd
- City
- Billerica
- State
- MA
- Postal Code
- 01821
- Country
- US
- Correspondent
- Carlos O Acosta
US Agent
- Business Name
- Omni-Guide Holdings, Inc.
- Contact Name
- Carlos Acosta
- Address
- 43 Manning Road
- City
- Billerica
- State
- MA
- ZIP
- 01821
- Country
- US
- [email protected]
- Phone
- 617 5514400 ext. 563
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2021-12-30 |
Proprietary Names
RevoLix and R Jr
Establishment Types
Manufacture Medical Device