FDA UDI
In Commercial Distribution
🇺🇸 United States
Beacon Advanced Energy CO2 Laser System
DI: 00852306007715
·
Model: 60 Watt
·
OMNIGUIDE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Beacon Advanced Energy CO2 Laser System
- Primary DI
- 00852306007715
- Version / Model
- 60 Watt
- Catalog Number
- 420060-AA
- Company Name
- OMNIGUIDE, INC.
- Labeler DUNS
- 030124221
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-02
- Public Version
- 2
- Public Version Date
- 2019-06-06
- Public Version Status
- Update
- Public Device Record Key
- 8ff38e0d-cbcb-4803-b993-e0e484bc10b6
Device Description
A 30 watt Beacon Advanced Energy CO2 Laser System for Surgical use with ability to use line of sight laser energy or fiber supplied laser energy for use with the OmniGuide waveguide laser fiber
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 |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63069 | General/multiple surgical diode/carbon dioxide laser system | A mains electricity (AC-powered) device assembly designed to produce two distinct high-power laser beams, one diode mediated, and the other carbon dixoide (CO2) mediated, intended for aesthetic and tissue reconstructive applications across multiple clinical specialties (e.g., dermatological, gynaecological, urological applications) using both ablative and non-ablative lasing. It includes a laser generator with controls and a monitor. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852306007715 | GS1 |
Customer Contacts
- Phone
- 888-666-4484
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180993 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 70 Degrees Celsius