FDA.reportPublic FDA data

D-STORM

Primary DI
07290016784039
Brand
D-STORM
Company
LIGHT INSTRUMENTS LTD
Model
1
Catalog number
LI-FGD001(X)
Device description
Diode (portable)
Published
2023-01-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K093048000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093048000D-STORM 810NM, D-STORM 980NMLight Instruments2010-03-23GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016784039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016784039072900167840397290016784039

GMDN Terms#

Term, Definition table
TermDefinition
Dental 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 for application in dental procedures; it does not include frequency-doubling technology. It typically includes a light source, delivery/positioning device(s), controls/foot-switch. It is intended to incise, excise, vaporize, ablate, and coagulate oral soft tissue; and cut, shave, contour, and resect oral bone/teeth. Its high-water affinity and high-fluency pulses produce an exceptionally narrow zone of damage around the soft-tissue vaporization crater.

Regulatory Flags#

DUNS number
514489314
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016784046D-STORM1LI-FGD002(X)2023-01-08
07290016784008TIP for LITETOUCHD-1.0 mm L-10 mmAS7078X 2022-12-01
07290016784053TIP for LITETOUCHD-0.8 mm L-8 mmAS7077X 2022-12-01
07290016784060TIP for LITETOUCHENDO LI-FG4001(X)2022-12-01
07290016784015LiteTouchLI-FG0012ALI-FG0012A2017-01-01
07290016784022LiteTouch ApplicatorLI-FG0015ALI-FG0015A2017-01-01
07290016784107E1 Handpiece, LTAS78251AS782512017-01-01
07290016784114Straight Handpiece, LTAS72301AS723012017-01-01
07290016784206TIP for LITETOUCHSPECIALTY TIPS SIDED ALI-AS300402017-01-01
07290016784213TIP for LITETOUCH SPECIALTLY TIPS SIDE BLI-AS300502017-01-01
07290016784305TIP for LITETOUCHD-0.2mm L-17mm AS756512017-01-01
07290016784312TIP for LITETOUCHD-0.4mm L-17mm AS707522017-01-01
07290016784329TIP for LITETOUCHD-0.6mm L-17mm AS707222017-01-01
07290016784336TIP for LITETOUCHD-0.8mm L-14mm AS707422017-01-01
07290016784343TIP for LITETOUCHD-0.8mm L-17mmAS706922017-01-01
07290016784350TIP for LITETOUCHD-1.0mm L-14mm AS707322017-01-01
07290016784367TIP for LITETOUCHD-1.0mm L-17mmAS706822017-01-01
07290016784374TIP for LITETOUCHD-1.3mm L-14mm AS706622017-01-01
07290016784381TIP for LITETOUCHD-1.3mm L-17mmAS706522017-01-01
07290016784398TIP for LITETOUCHD-1.3mm L-19mm AS707122017-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851088019BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
08800020109446TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109453TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109460TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109477TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109484TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109491TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109507TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109514TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109521TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109538TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109545TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109552TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109651Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109668Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109675Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109682Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109699Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109705Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109712Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109729Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109989FootswitchJeisys Medical Inc.GEX2026-07-16
08800020109996FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110008FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110275SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110282SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110299SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16