FDA UDI
In Commercial Distribution
🇺🇸 United States
iLase Diode Laser System
DI: 00647529002322
·
Model: iLase
·
Biolase, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- iLase Diode Laser System
- Primary DI
- 00647529002322
- Version / Model
- iLase
- Catalog Number
- 7400040-01
- Company Name
- Biolase, Inc.
- Labeler DUNS
- 152165700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 7
- Public Version Date
- 2023-06-12
- Public Version Status
- Update
- Public Device Record Key
- 68e91b11-15a4-40ed-81d5-6fb79c37efbb
Device Description
iLase Diode Laser System is designed for a variety of dental soft tissue procedures. The iLase system consists of one iLase handpiece and the iLase charging station used for charging and storing the handpiece and replacement batteries. Other systems components include protective eyewear, rechargeable batteries, charging station power supply, handpiece cover grips, laser tips and a tip cleaning kit. The handpiece is a reusable device with a removable cover which requires sterilization prior to each patient use.
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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|
| 60340 | Dental diode laser system | A mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to cut, excise, vaporize, and coagulate oral tissues in various dental applications such as oral soft-tissue surgery, gingivectomy, to diminish inflammation, and for oral therapy and tooth whitening; it is not a dedicated tooth-bleaching acceleration unit. It includes a portable diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch; it may include a rechargeable battery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00647529002322 | GS1 |
Customer Contacts
- Phone
- 1-800-321-6717
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K093852 | 000 |