FDA.reportPublic FDA data

Focal Guide 6 x 6

Primary DI
10841494100589
Brand
Focal Guide 6 x 6
Company
Cynosure, Inc.
Model
5520-2027
Device description
Focal Guide 6 x 6
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
ONGPowered laser surgical instrument with microbeam\fractional output

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONGPowered Laser Surgical Instrument With MicrobeamFractional OutputGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841494100589PackageGS15In Commercial Distribution
00841494100582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084149410058910841494100589
00841494100582008414941005828414941005820841494100582

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin surface treatment systemA mains electricity (AC-powered) mobile (on wheels) assembly of devices that uses multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, and radio-frequency (RF) energy] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes a lamp(s) and additional energy sources (typically a laser(s), and/or a RF generator); dedicated applicators (handpieces) intended to apply the different energies to the skin are also included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
780318028
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
10841494100022Focus Cap Array100-7012-0552016-09-24
10841494100503Affirm 10mm Tip100-7004-9102016-09-24
10841494100510Affirm, 14mm Tip100-7004-8142016-09-24
10841494103511MaxG 4mm Adapter2520-00272016-09-24
10841494100473SlimlipoTip 175 mm, EO0320-00312016-09-24
10841494100596Focal Guide 10 x 105520-20242016-09-24
10841494103573MaxYs 4mm Adapter2520-00452016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800291821160eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
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08800291821191eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821207eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821214eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821221eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821238eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821245eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821252eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821269eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821276eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821283eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821290eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821306eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821313eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821320eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821337eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
06974077940023MLKJWeifang Mingliang Electronics Co., Ltd.ONG2025-09-17
06970745912323ApolomedShanghai Apolo Medical Technology Co.,LtdONG2025-07-21
06970745912330ApolomedShanghai Apolo Medical Technology Co.,LtdONG2025-07-21
08057622080004MTONE EVOM & T SRLONG2025-04-15
08057622080011MTONE EVOM & T SRLONG2025-04-15
08057622080028MT ONEM & T SRLONG2025-04-15
08057622080035MT ONEM & T SRLONG2025-04-15
08057622080042MT ONE DIAMONDM & T SRLONG2025-04-15
G7433426Smooth Beauty LaserTria Laser IncONG2025-03-07
08800016903959Fraxis Set PackageCLASSYS Inc.ONG2024-10-30
08800016903966Fraxis Main UnitCLASSYS Inc.ONG2024-10-30
08800016903973Fraxis HandpieceCLASSYS Inc.ONG2024-10-30