FDA.reportPublic FDA data

KLARO In Vivo Surgical Lighting

Primary DI
08881300212001
Brand
KLARO In Vivo Surgical Lighting
Company
VIVO SURGICAL PRIVATE LIMITED
Model
555-01-01
Catalog number
555-01-01
Device description
"KLARO is a deep-cavity surgical LED lighting device for open surgery use. It is discreet, easy to use and provides bright, uniform and localised ""flood-lighting"" from within the surgical site. KLARO maintains a safe and cool working temperature suited for use inside the human body regardless of the luminous intensity selected."
Published
2023-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTDLamp, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTDLamp, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08881300212018PackageGS15In Commercial Distribution
08881300212025PackageGS12In Commercial Distribution
08881300212001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08881300212018088813002120188881300212018
08881300212025088813002120258881300212025
08881300212001088813002120018881300212001

GMDN Terms#

Term, Definition table
TermDefinition
Open surgical site internal lightAn electrically-powered, light-emitting device that includes a light source and is intended to be placed within, or nearly within, a surgical wound/site for illumination during open surgery. It may be fixed to a surgical instrument (e.g., a retractor) and typically operates with either fibreoptic or LED technology to create cold light. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity40 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+6566770395regulatory@vivo-surgical.com

Regulatory Flags#

DUNS number
659504181
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08881300212018KLARO In Vivo Surgical Lighting555-01-01555-01-012023-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850036790020AliteRevelle Aesthetics, Inc.FTD2025-09-01
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