FDA UDI
In Commercial Distribution
🇺🇸 United States
Perfecta Delivery System, Refurbished
DI: 00817495024608
·
Model: FIN100984
·
Candela Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Perfecta Delivery System, Refurbished
- Primary DI
- 00817495024608
- Version / Model
- FIN100984
- Company Name
- Candela Corporation
- Labeler DUNS
- 053468385
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-24
- Public Version
- 1
- Public Version Date
- 2023-06-20
- Public Version Status
- New
- Public Device Record Key
- 543252c0-ed12-4c9b-89f6-7192b1d11a4f
Device Description
Perfecta Delivery System, Refurbished
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 |
|---|---|---|---|---|
| 57890 | Dermatological dye laser system | A mains electricity (AC-powered) Light Amplification by Stimulated Emission of Radiation (LASER) device assembly in which input energy is used to excite organic compounds (i.e., dye) used as the active medium to emit a beam of intense, coherent, monochromatic electromagnetic (EM) radiation to incise, excise, ablate, and vaporize soft tissues for dermatological applications such vascular/skin lesion, acne and wrinkle removal or reduction. It typically includes a light source, flexible fibreoptic delivery/positioning device(s), and controls/foot-switch for pulsed mode operation. During emission the dye has to be optically excited by another light source (e.g., another laser or flash lamp). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817495024608 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230990 | 000 |