FDA.reportPublic FDA data

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

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250776000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850069558666PackageGS15In Commercial Distribution
00850069558246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850069558666008500695586668500695586660850069558666
00850069558246008500695582468500695582460850069558246

GMDN Terms#

Term, Definition table
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 table
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 table
Primary DIBrandModelCatalogPublished
00850069558154Lithoblast Single-Use Holmium Laser FibersLB272BH-BS-C2026-03-10
00850069558574Lithoblast Single-Use Holmium Laser FibersLB272BH-BS-C2026-03-10
00850069558130Lithoblast Single-Use Holmium Laser Fibers LB272BH-BS-A2026-03-02
00850069558147Lithoblast Single-Use Holmium Laser Fibers LB272BH-BS-B2026-03-02
00850069558161Lithoblast Single-Use Holmium Laser Fibers LB272BH-AG-A2026-03-02
00850069558178Lithoblast Single-Use Holmium Laser Fibers LB272BH-AG-B2026-03-02
00850069558185Lithoblast Single-Use Holmium Laser Fibers LB272BH-AG-C2026-03-02
00850069558192Lithoblast Single-Use Holmium Laser Fibers LB365BH-REG-A2026-03-02
00850069558208Lithoblast Single-Use Holmium Laser Fibers LB365BH-REG-B2026-03-02
00850069558215Lithoblast Single-Use Holmium Laser Fibers LB365BH-REG-C2026-03-02
00850069558222Lithoblast Single-Use Holmium Laser Fibers LB365BH-BS-A2026-03-02
00850069558239Lithoblast Single-Use Holmium Laser Fibers LB365BH-BS-B2026-03-02
00850069558246Lithoblast Single-Use Holmium Laser Fibers LB365BH-BS-C2026-03-02
00850069558253Lithoblast Single-Use Holmium Laser Fibers LB365BH-AG-A2026-03-02
00850069558260Lithoblast Single-Use Holmium Laser Fibers LB365BH-AG-B2026-03-02
00850069558277Lithoblast Single-Use Holmium Laser Fibers LB365BH-AG-C2026-03-02
00850069558284Lithoblast Single-Use Holmium Laser Fibers LB550BH-REG-A2026-03-02
00850069558291Lithoblast Single-Use Holmium Laser Fibers LB550BH-REG-B2026-03-02
00850069558307Lithoblast Single-Use Holmium Laser Fibers LB550BH-REG-C2026-03-02
00850069558314Lithoblast Single-Use Holmium Laser Fibers LB550BH-BS-A2026-03-02

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