FDA.report

Lithoblast Single-Use Holmium Laser Fibers

Primary DI
00850069558796
Brand
Lithoblast Single-Use Holmium Laser Fibers
Company
DAWELL MEDICAL, LLC
Model
LB940BH-REG-A
Device description
940 µm Laser Fiber Regular A
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

CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions

SubmissionSupplement
K250776000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K250776000Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC2025-10-14GEX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850069558796PackageGS15In Commercial Distribution
00850069558376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850069558796008500695587968500695587960850069558796
00850069558376008500695583768500695583760850069558376

GMDN Terms

TermDefinition
Dermatological frequency-doubled solid-state laser systemA 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 DIBrandModelCatalogPublished
00850069558574Lithoblast Single-Use Holmium Laser FibersLB272BH-BS-C2026-03-10
00850069558109Lithoblast Single-Use Holmium Laser Fibers LB272BH-REG-A2026-03-02
00850069558116Lithoblast Single-Use Holmium Laser Fibers LB272BH-REG-B2026-03-02
00850069558123Lithoblast Single-Use Holmium Laser Fibers LB272BH-REG-C2026-03-02
00850069558550Lithoblast Single-Use Holmium Laser Fibers LB272BH-BS-A2026-03-02
00850069558567Lithoblast Single-Use Holmium Laser Fibers LB272BH-BS-B2026-03-02
00850069558581Lithoblast Single-Use Holmium Laser Fibers LB272BH-AG-A2026-03-02
00850069558598Lithoblast Single-Use Holmium Laser Fibers LB272BH-AG-B2026-03-02
00850069558604Lithoblast Single-Use Holmium Laser Fibers LB272BH-AG-C2026-03-02
00850069558611Lithoblast Single-Use Holmium Laser Fibers LB365BH-REG-A2026-03-02
00850069558628Lithoblast Single-Use Holmium Laser Fibers LB365BH-REG-B2026-03-02
00850069558635Lithoblast Single-Use Holmium Laser Fibers LB365BH-REG-C2026-03-02
00850069558642Lithoblast Single-Use Holmium Laser Fibers LB365BH-BS-A2026-03-02
00850069558659Lithoblast Single-Use Holmium Laser Fibers LB365BH-BS-B2026-03-02
00850069558666Lithoblast Single-Use Holmium Laser Fibers LB365BH-BS-C2026-03-02
00850069558673Lithoblast Single-Use Holmium Laser Fibers LB365BH-AG-A2026-03-02
00850069558680Lithoblast Single-Use Holmium Laser Fibers LB365BH-AG-B2026-03-02
00850069558697Lithoblast Single-Use Holmium Laser Fibers LB365BH-AG-C2026-03-02
00850069558703Lithoblast Single-Use Holmium Laser Fibers LB550BH-REG-A2026-03-02
00850069558710Lithoblast Single-Use Holmium Laser Fibers LB550BH-REG-B2026-03-02

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00850069558574Lithoblast Single-Use Holmium Laser FibersDAWELL MEDICAL, LLCGEX2026-03-10
00850069558109Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558116Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558123Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558550Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558567Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558581Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558598Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558604Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558611Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558628Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558635Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558642Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558659Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558666Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558673Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558680Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558697Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02