Fraxel
- Primary DI
- 00816995020288
- Brand
- Fraxel
- Company
- SOLTA MEDICAL
- Model
- MC-TIP-RE:PAIR-4S
- Catalog number
- MC-TIP-RE:PAIR-4S
- Device description
- FRAXEL RE:PAIR TIPS (4-SMALL)
- Published
- 2016-09-23
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| GEX | Powered Laser Surgical Instrument |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00816995020288 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00816995020288 | 00816995020288 | 816995020288 | 0816995020288 |
GMDN Terms
| Term | Definition |
|---|---|
| Dermatological carbon dioxide laser system | A mains electricity (AC-powered) device assembly in which input energy is used to excite carbon dioxide (CO2) to emit a high-power laser beam, intended to incise, excise, ablate, and vaporize soft tissues for dermatological applications such as skin resurfacing, scar treatment, skin tightening, and lesion/hair/tattoo removal. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 079999584
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
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|---|---|---|---|---|
| 00816995027775 | Fraxel FTX | MC15MM12 | MC15MM12 | 2025-04-02 |
| 00816995027782 | Fraxel FTX | MC7MM12 | MC7MM12 | 2025-04-02 |
| 00816995027799 | Fraxel FTX | MCSYSFTX-R | MCSYSFTX-R | 2025-04-02 |
| 00816995027805 | Fraxel FTX | MCSYSFTX | MCSYSFTX | 2025-04-02 |
| 00816995021513 | VASER | P010338-03 | P010338-03 | 2022-04-08 |
| 00816995022633 | ORIGINS | 810-MCBT5033PXNR | 810-MCBT5033PXNR | 2022-04-08 |
| 00816995022664 | ORIGINS | 810-MCBU3020LLNR | 810-MCBU3020LLNR | 2022-04-08 |
| 00816995022718 | ORIGINS | 810-MCBU3030VXNR | 810-MCBU3030VXNR | 2022-04-08 |
| 00816995022787 | ORIGINS | 810-MCBU4030PXNR | 810-MCBU4030PXNR | 2022-04-08 |
| 00816995022800 | ORIGINS | 810-MCBU4030VXNR | 810-MCBU4030VXNR | 2022-04-08 |
| 00816995022879 | ORIGINS | 810-MCBU5030PXNR | 810-MCBU5030PXNR | 2022-04-08 |
| 00816995022893 | ORIGINS | 810-MCBU5030VXNR | 810-MCBU5030VXNR | 2022-04-08 |
| 00816995022916 | ORIGINS | 810-MDMD3030PXNR | 810-MDMD3030PXNR | 2022-04-08 |
| 00816995022947 | ORIGINS | 810-MDMD4030PXNR | 810-MDMD4030PXNR | 2022-04-08 |
| 00816995022978 | ORIGINS | 810-MDMD5030PXNR | 810-MDMD5030PXNR | 2022-04-08 |
| 00816995023005 | ORIGINS | 810-MDMD6030PXNR | 810-MDMD6030PXNR | 2022-04-08 |
| 00816995023050 | ORIGINS | 810-SGBU4030PXNR | 810-SGBU4030PXNR | 2022-04-08 |
| 00816995023173 | ORIGINS | 810-SLBU4026PXNR | 810-SLBU4026PXNR | 2022-04-08 |
| 00816995023418 | ORIGINS | 810-SPSP4033VXNR | 810-SPSP4033VXNR | 2022-04-08 |
| 00816995023500 | ORIGINS | 810-STBT3026BDCX | 810-STBT3026BDCX | 2022-04-08 |
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|---|---|---|---|---|
| 08052286590500 | LASER THERMAL THERAPY KIT S E | ELESTA SPA | GEX | 2026-03-24 |
| 08052286590517 | LASER THERMAL THERAPY KIT L E | ELESTA SPA | GEX | 2026-03-24 |
| 06975617991024 | DIODE LASER FOR HIAR REMOVAL | BEIJING HONKON TECHNOLOGIES CO., LTD. | GEX | 2026-03-23 |
| 06975617992014 | Q-SWITCHED ND:YAG LASER | BEIJING HONKON TECHNOLOGIES CO., LTD. | GEX | 2026-03-23 |
| 06975617993011 | CO2 FRACTIONAL LASER | BEIJING HONKON TECHNOLOGIES CO., LTD. | GEX | 2026-03-23 |
| 16977331780080 | GigaaMed | Gigaalaser Company Ltd. | GEX | 2026-03-19 |
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| 00860015460639 | NextGen Aesthetics LHR | T AESTHETICS LLC | GEX | 2026-03-12 |
| 08034108512877 | TORO | DEKA M.E.L.A. SRL | GEX | 2026-03-11 |
| 00850069558574 | Lithoblast Single-Use Holmium Laser Fibers | DAWELL MEDICAL, LLC | GEX | 2026-03-10 |
| 00850069558109 | Lithoblast Single-Use Holmium Laser Fibers | DAWELL MEDICAL, LLC | GEX | 2026-03-02 |
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| 00850069558604 | Lithoblast Single-Use Holmium Laser Fibers | DAWELL MEDICAL, LLC | GEX | 2026-03-02 |
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