Lithoblast Single-Use Holmium Laser Fibers
- Primary DI
- 00850069558666
- Brand
- Lithoblast Single-Use Holmium Laser Fibers
- Company
- DAWELL MEDICAL, LLC
- Model
- LB365BH-BS-C
- Device description
- 365 µm Laser Fiber Blast Shield C
- Published
- 2026-03-02
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
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 |
Premarket Submissions
| Submission | Supplement |
|---|---|
| K250776 | 000 |
Premarket Details
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00850069558666 | Package | GS1 | 5 | In Commercial Distribution |
| 00850069558246 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00850069558666 | 00850069558666 | 850069558666 | 0850069558666 |
| 00850069558246 | 00850069558246 | 850069558246 | 0850069558246 |
GMDN Terms
| Term | Definition |
|---|---|
| Dermatological frequency-doubled solid-state laser system | A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended to cut, excise, ablate, and vaporize soft tissues in dermatological applications such as vascular/skin lesion, tattoo, and hair removal; it includes frequency doubling technology whereby the operator can select one of two energy wavelengths (1064 or 532 nm); it may include additional glass/crystal rods and pumping options to achieve additional laser wavelengths. It includes a light source, delivery/positioning device(s), and controls/foot-switch, and may be operated in continuous-wave or pulsed modes. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 131865439
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00850069558574 | Lithoblast Single-Use Holmium Laser Fibers | LB272BH-BS-C | 2026-03-10 | |
| 00850069558109 | Lithoblast Single-Use Holmium Laser Fibers | LB272BH-REG-A | 2026-03-02 | |
| 00850069558116 | Lithoblast Single-Use Holmium Laser Fibers | LB272BH-REG-B | 2026-03-02 | |
| 00850069558123 | Lithoblast Single-Use Holmium Laser Fibers | LB272BH-REG-C | 2026-03-02 | |
| 00850069558550 | Lithoblast Single-Use Holmium Laser Fibers | LB272BH-BS-A | 2026-03-02 | |
| 00850069558567 | Lithoblast Single-Use Holmium Laser Fibers | LB272BH-BS-B | 2026-03-02 | |
| 00850069558581 | Lithoblast Single-Use Holmium Laser Fibers | LB272BH-AG-A | 2026-03-02 | |
| 00850069558598 | Lithoblast Single-Use Holmium Laser Fibers | LB272BH-AG-B | 2026-03-02 | |
| 00850069558604 | Lithoblast Single-Use Holmium Laser Fibers | LB272BH-AG-C | 2026-03-02 | |
| 00850069558611 | Lithoblast Single-Use Holmium Laser Fibers | LB365BH-REG-A | 2026-03-02 | |
| 00850069558628 | Lithoblast Single-Use Holmium Laser Fibers | LB365BH-REG-B | 2026-03-02 | |
| 00850069558635 | Lithoblast Single-Use Holmium Laser Fibers | LB365BH-REG-C | 2026-03-02 | |
| 00850069558642 | Lithoblast Single-Use Holmium Laser Fibers | LB365BH-BS-A | 2026-03-02 | |
| 00850069558659 | Lithoblast Single-Use Holmium Laser Fibers | LB365BH-BS-B | 2026-03-02 | |
| 00850069558673 | Lithoblast Single-Use Holmium Laser Fibers | LB365BH-AG-A | 2026-03-02 | |
| 00850069558680 | Lithoblast Single-Use Holmium Laser Fibers | LB365BH-AG-B | 2026-03-02 | |
| 00850069558697 | Lithoblast Single-Use Holmium Laser Fibers | LB365BH-AG-C | 2026-03-02 | |
| 00850069558703 | Lithoblast Single-Use Holmium Laser Fibers | LB550BH-REG-A | 2026-03-02 | |
| 00850069558710 | Lithoblast Single-Use Holmium Laser Fibers | LB550BH-REG-B | 2026-03-02 | |
| 00850069558727 | Lithoblast Single-Use Holmium Laser Fibers | LB550BH-REG-C | 2026-03-02 |
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| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 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 |
| 02816901023318 | NeuLight® | Weinert Fiber Optics, Inc. | GEX | 2026-03-12 |
| 02816901024032 | NeuLight® | Weinert Fiber Optics, Inc. | GEX | 2026-03-12 |
| 01816901024156 | NeuLight® | Weinert Fiber Optics, Inc. | GEX | 2026-03-12 |
| 00860015460615 | NextGen Aesthetics CO2 | T AESTHETICS LLC | GEX | 2026-03-12 |
| 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 |
| 00850069558116 | Lithoblast Single-Use Holmium Laser Fibers | DAWELL MEDICAL, LLC | GEX | 2026-03-02 |
| 00850069558123 | Lithoblast Single-Use Holmium Laser Fibers | DAWELL MEDICAL, LLC | GEX | 2026-03-02 |
| 00850069558550 | Lithoblast Single-Use Holmium Laser Fibers | DAWELL MEDICAL, LLC | GEX | 2026-03-02 |
| 00850069558567 | Lithoblast Single-Use Holmium Laser Fibers | DAWELL MEDICAL, LLC | GEX | 2026-03-02 |
| 00850069558581 | Lithoblast Single-Use Holmium Laser Fibers | DAWELL MEDICAL, LLC | GEX | 2026-03-02 |
| 00850069558598 | Lithoblast Single-Use Holmium Laser Fibers | DAWELL MEDICAL, LLC | GEX | 2026-03-02 |
| 00850069558604 | Lithoblast Single-Use Holmium Laser Fibers | DAWELL MEDICAL, LLC | GEX | 2026-03-02 |
| 00850069558611 | Lithoblast Single-Use Holmium Laser Fibers | DAWELL MEDICAL, LLC | GEX | 2026-03-02 |
| 00850069558628 | Lithoblast Single-Use Holmium Laser Fibers | DAWELL MEDICAL, LLC | GEX | 2026-03-02 |
| 00850069558635 | Lithoblast Single-Use Holmium Laser Fibers | DAWELL MEDICAL, LLC | GEX | 2026-03-02 |
| 00850069558642 | Lithoblast Single-Use Holmium Laser Fibers | DAWELL MEDICAL, LLC | GEX | 2026-03-02 |
| 00850069558659 | Lithoblast Single-Use Holmium Laser Fibers | DAWELL MEDICAL, LLC | GEX | 2026-03-02 |
| 00850069558673 | Lithoblast Single-Use Holmium Laser Fibers | DAWELL MEDICAL, LLC | GEX | 2026-03-02 |
| 00850069558680 | Lithoblast Single-Use Holmium Laser Fibers | DAWELL MEDICAL, LLC | GEX | 2026-03-02 |
| 00850069558697 | Lithoblast Single-Use Holmium Laser Fibers | DAWELL MEDICAL, LLC | GEX | 2026-03-02 |
| 00850069558703 | Lithoblast Single-Use Holmium Laser Fibers | DAWELL MEDICAL, LLC | GEX | 2026-03-02 |