FDA.reportPublic FDA data

LOTUS III User Manual

Primary DI
08800035500566
Brand
LOTUS III User Manual
Company
Laseroptek Co.,Ltd
Model
LOTUS III User Manual
Device description
LOTUS III User Manual
Published
2019-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K182045000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182045000Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.2018-12-27GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800035500566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800035500566088000355005668800035500566

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical 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 general surgery and/or multiple specialized surgical applications (non-dedicated), which may include treatment of vascular diseases. It vaporizes/ablates soft tissue with moderate haemostasis, little charring, and a thin zone of necrosis. It includes a light source, delivery/positioning device(s), and controls/foot-switch and emits a midinfrared wavelength. It does not include frequency doubling technology.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Regulatory Flags#

DUNS number
689856875
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800035500412HYPERION bodyHYPERION body2018-01-12
08800035500306HYPERION power cableHYPERION power cable2018-01-12
08800035500429HYPERION ArmHYPERION Arm2018-01-12
08800035500436HYPERION Gold HandpieceHYPERION Gold Handpiece2018-01-12
08800035500443HYPERION Red HandpieceHYPERION Red Handpiece2018-01-12
08800035500450HYPERION Blue HandpieceHYPERION Blue Handpiece2018-01-12
08800035500467HYPERION User ManualHYPERION User Manual2018-01-12
08800035500474HYPERION Service ManualHYPERION Service Manual2018-01-12
08800035500481HYPERION Foot SwitchHYPERION Foot Switch2018-01-12
08800035500511HYPERION FIBERHYPERION FIBER2018-04-16
08800035500788HELIOS III bodyHELIOS III body2019-11-21
08800035501860HELIOS 785 Pico BodyHELIOS 785 Pico (1754V2) Body2025-02-18
08800035500740HELIOS III bodyHELIOS III body2019-11-21
08800035500795HELIOS III ArmHELIOS III Arm2019-11-21
08800035500801HELIOS III Zoom HandpieceHELIOS III Zoom Handpiece2019-11-21
08800035500818HELIOS III 532 HandpieceHELIOS III 532 Handpiece2019-11-21
08800035500825HELIOS III 1064 HandpieceHELIOS III 1064 Handpiece2019-11-21
08800035500832HELIOS III Collimator HandpieceHELIOS III Collimator Handpiece2019-11-21
08800035500849HELIOS III User ManualHELIOS III User Manual2019-11-21
08800035500856HELIOS III Service ManualHELIOS III Service Manual2019-11-21

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