FDA Registration
Active
🇺🇸 United States
ROHRER AESTHETICS, INC.
Reg #: 3031944951
·
FEI: 3031944951
·
Expires 2026
Products
8
Proprietary Names
15
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- ROHRER AESTHETICS, INC.
- Registration Number
- 3031944951
- FEI Number
- 3031944951
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 121 Citation Ct
- City
- Homewood
- State
- AL
- ZIP
- 35209
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233099
Owner / Operator
- Firm Name
- Rohrer Aesthetics, Inc.
- Operator Number
- 10091003
- Address
- 121 Citation Court
- City
- Homewood
- State
- AL
- Postal Code
- 35209
- Country
- US
- Correspondent
- Sandra Hansen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | IMG | Class 2 | Physical Medicine | No | 2024-07-05 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2024-07-05 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2024-07-05 |
| Skin Resurfacing Rf Applicator | OUH | Class 2 | General, Plastic Surgery | No | 2024-07-05 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2024-07-05 |
| Laser For Disruption Of Adipocyte Cells For Aesthetic Use | PKT | Class 2 | General, Plastic Surgery | No | 2024-07-05 |
| Fat Reducing Low Level Laser | OLI | Class 2 | General, Plastic Surgery | No | 2024-07-05 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2024-07-05 |
Proprietary Names
Gladiator
VeinGo
Light Bed
EpiLaze
Pix-E
BodySculp
Phoenix
Pixel8-RF
Apollo
Spectrum
PicoLazer
UltraLight LED
BodyTone
InPulsa
PiXel8
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility