FDA UDI
In Commercial Distribution
🇺🇸 United States
LASER THERMAL THERAPY KIT S E
DI: 08052286590500
·
Model: EI KT0 0011 001
·
ELESTA SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LASER THERMAL THERAPY KIT S E
- Primary DI
- 08052286590500
- Version / Model
- EI KT0 0011 001
- Company Name
- ELESTA SPA
- Labeler DUNS
- 895683282
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-24
- Public Version
- 1
- Public Version Date
- 2026-04-01
- Public Version Status
- New
- Public Device Record Key
- 689293d8-05ab-4187-960d-62cf1397e535
Device Description
One box containing 20 fibers (Fiber Optic for PLA S) and 20 needles (S)
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 62600 | General/multiple surgical laser system beam guide, single-use | A surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials; a fibreoptic cable may be included with the device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08052286590500 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K260632 | 000 |