FDA.reportPublic FDA data

Lithoblast Single-Use Holmium Laser Fibers

Primary DI
00850069558161
Brand
Lithoblast Single-Use Holmium Laser Fibers
Company
DAWELL MEDICAL, LLC
Model
LB272BH-AG-A
Device description
272 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
00850069558581PackageGS15In Commercial Distribution
00850069558161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850069558581008500695585818500695585810850069558581
00850069558161008500695581618500695581610850069558161

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
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
00850069558321Lithoblast Single-Use Holmium Laser Fibers LB550BH-BS-B2026-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898672790823Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-12
08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
08057017760733DEKA TRUISTEL.EN. SPAGEX2023-04-27
08059173390243Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390274Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390304Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390335Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390366Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390397Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390427Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390458Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
08059173391882Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2021-03-17
08059173391912Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2021-03-17
08059173391196Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2020-06-09
08059173390724Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
08059173390755Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
08059173390786Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
08057017760429DEKA LUXEAEL.EN. SPAGEX2020-01-15
08056389700071E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
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