FDA UDI
In Commercial Distribution
🇺🇸 United States
Zerona 2.0
DI: 00858985006100
·
Model: GLS
·
ERCHONIA CORPORATION, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Zerona 2.0
- Primary DI
- 00858985006100
- Version / Model
- GLS
- Catalog Number
- GLS
- Company Name
- ERCHONIA CORPORATION, LLC
- Labeler DUNS
- 004053174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 28194bb8-584a-4a59-b74d-dcf9de97b5cc
Device Description
AESTHETIC - Floor Model Low Level Laser -- 6 diodes 532nm 17mW - IFU Reduction Circumference
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OLI | Fat Reducing Low Level Laser | General, Plastic Surgery | 878.5400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58252 | Low-intensity laser fat liquefaction system | An assembly of devices designed for the noninvasive application of low-level laser energy [low-level laser therapy (LLLT)] to liquefy (emulsify) subcutaneous and visceral adipose tissue (fat) for cosmetic/aesthetic (e.g., body contouring, circumference reduction) and medical (e.g. weight-loss, lipid reduction) applications. It is a mains electricity (AC-powered) system, mobile on wheels, which incorporates laser diode modules on adjustable arms, a control monitor, and software. It is an independent, primary device which may be used as an adjunct modality in conjunction with liposuction and surgical techniques as a secondary function. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858985006100 | GS1 |
Customer Contacts
- Phone
- (888) 242-0571
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123237 | 000 |