FDA.reportPublic FDA data

Lithoblast Single-Use Holmium Laser Fibers

Primary DI
00850069558345
Brand
Lithoblast Single-Use Holmium Laser Fibers
Company
DAWELL MEDICAL, LLC
Model
LB550BH-AG-A
Device description
550 µm Laser Fiber Air Gap 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
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
00850069558765PackageGS15In Commercial Distribution
00850069558345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850069558765008500695587658500695587650850069558765
00850069558345008500695583458500695583450850069558345

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.

Regulatory Flags#

DUNS number
131865439
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
08057017760733DEKA TRUISTEL.EN. SPAGEX2023-04-27
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08059173390724Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
08059173390755Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
08057017760429DEKA LUXEAEL.EN. SPAGEX2020-01-15
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08056389700088E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08057017760276DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760283DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760344DEKA MOTUS AYEL.EN. SPAGEX2019-03-15
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