FDA.reportPublic FDA data

Laguna Edge (2M)

Primary DI
00667259004007
Brand
Laguna Edge (2M)
Company
Silhouet-Tone Corporation
Model
412005
Published
2025-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LGXTable, Examination, Medical, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGXTable, Examination, Medical, PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00667259004007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00667259004007006672590040076672590040070667259004007

GMDN Terms#

Term, Definition table
TermDefinition
General examination/treatment chair, electricA mains electricity (AC-powered) device designed to support and position the patient in a seated or reclined posture for easy access and patient comfort during a diagnostic examination, medical treatment, and/or surgical procedure across specialties. It usually has moveable components and may include special features such as a raising and lowering mechanism and removable arms; it may have an integrated weighing scale. For chairs involving the use of medical systems that emit and/or detect energy (e.g., ionizing or non-ionizing radiation, ultrasound, heat, light) see the respective chair terms for those systems.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
242049828
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00667259003963EVOLUTION XHD4110272025-07-09
00667259003970EVOLUTION ST3504111032025-07-09
00667259001952Soli-Lite LG2 Spectra4115602018-08-24
00667259001600PR Cell 2G4113212018-08-24
00667259003871ELITE PLATINUM LINAK (BI-V)4122682022-07-19
00667259001563ST2504111012018-08-24
00667259003796EVOLUTION 7HD SEQUENTIAL4110172018-09-17
00667259003901ELITE SERIE MD-100 W/O Accessories Table4122522021-09-09
00667259003918ELITE SERIE MD-100-With 2 Arm Support Table4122532021-09-09
00667259003925ELITE SERIE MD-100-With 2 Stirrups Table4122542021-09-09
00667259003932ETNA TABLE (110V) 27 '' 2'' CUSHION WITH HEADREST4127002021-09-09
00667259003949ETNA SBF TABLE (110V) 27'' 2'' CUSHION WITH HEADREST4127162021-09-09
00667259003956ETNA SBF TABLE (110V) 27'' 4'' CUSHION WITH HEADREST4127182021-09-09
00667259003895Soli-Lite LG4 Galileo4115692020-08-17
00667259000030Laguna Mist Flex with Armrest 230V4120044120042017-06-16
00667259000016Laguna Mist 29' 230V4120024120022017-06-16
00667259000443Laguna Mist Flex with Armrest 230V4120044120042017-06-16
00667259000054Laguna Mist 32'' 230V4120144120142017-06-16
00667259003819ELITE SERIE MD-100-With 2 (Stirups & Arm Support) Table4122552019-04-25
00667259003826ELITE SERIE MD-100-With 2 (Stirups & Ergo Armrest) Table4122572019-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848871001500EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00848871001517EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00848871001524EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00848871001531EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00670482001071Echo-Flex 5002Umano Medical IncLGX2026-02-18
04260647941524ak 5010 MBSAKRUS GmbH & Co. KGLGX2025-11-28
04260647942040Additive Back support MBSAKRUS GmbH & Co. KGLGX2025-11-28
04260647942057Additive Back support (viscoel.) MBSAKRUS GmbH & Co. KGLGX2025-11-28
04260647942064Adapter footrest MBSAKRUS GmbH & Co. KGLGX2025-11-28
00728564057000Flex Access Exam TableThe Brewer Company LLCLGX2025-11-10
00728564057017Flex Access Exam TableThe Brewer Company LLCLGX2025-11-10
00728564058007Flex Access Exam TableThe Brewer Company LLCLGX2025-11-10
00728564058014Flex Access Exam TableThe Brewer Company LLCLGX2025-11-10
00728564060000Access Exam TableThe Brewer Company LLCLGX2025-11-10
00728564060017Access High-Low TableThe Brewer Company LLCLGX2025-11-10
00728564065005Access High-Low TableThe Brewer Company LLCLGX2025-11-10
00728564065012Access High-Low TableThe Brewer Company LLCLGX2025-11-10
00728564068006Access High-Low TableThe Brewer Company LLCLGX2025-11-10
00728564068013Access High-Low TableThe Brewer Company LLCLGX2025-11-10
00728564157007Flex Plus Access Exam TableThe Brewer Company LLCLGX2025-11-10
00728564157014Flex Plus Access Exam TableThe Brewer Company LLCLGX2025-11-10
00728564158004Flex Plus Access Exam TableThe Brewer Company LLCLGX2025-11-10
00728564158011Flex Plus Access Exam TableThe Brewer Company LLCLGX2025-11-10
00728564160007Access HLT Plus Exam TableThe Brewer Company LLCLGX2025-11-10
00728564160014Access HLT Plus Exam TableThe Brewer Company LLCLGX2025-11-10
00728564165002Access HLT Plus Exam TableThe Brewer Company LLCLGX2025-11-10
00728564165019Access HLT Plus Exam TableThe Brewer Company LLCLGX2025-11-10
00728564168003Access HLT Plus Exam TableThe Brewer Company LLCLGX2025-11-10
00728564168010Access HLT Plus Exam TableThe Brewer Company LLCLGX2025-11-10
00613647029268FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LGX2025-04-30