HOLLYWOOD SPECTRA

GUDID 08809447654775

Fractional Handpiece

Lutronic Corporation

General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system General/multiple surgical frequency-doubled solid-state laser system
Primary Device ID08809447654775
NIH Device Record Key90f84e77-a379-481c-8450-94995471ae67
Commercial Distribution StatusIn Commercial Distribution
Brand NameHOLLYWOOD SPECTRA
Version Model NumberFractional Handpiece
Company DUNS688282516
Company NameLutronic Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com
Phone408-912-1701
Emailjasonkim@lutronic.com

Operating and Storage Conditions

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108809447654775 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-05
Device Publish Date2021-01-28

On-Brand Devices [HOLLYWOOD SPECTRA]

088094476547518mm-Zoom-Collimated Handpiece
08809447654744Zoom Handpiece
088094476547372mm-SD650 Handpiece
088094476547202mm-SD585 Handpiece
08809447654713Gold Toning (5mm-SD585) Handpiece
08809447654805ARM_VA20_D-GRAY
08809447654690HOLLYWOOD SPECTRA_MANUAL_USA
08809447654799HOLLYWOOD SPECTRA SL USA 120V
08809447654782HOLLYWOOD SPECTRA OP USA 120V
08809447654768DUAL FOCUSED DOTS HP_HOLLYWOOD SPECTRA
08809447654775Fractional Handpiece

Trademark Results [HOLLYWOOD SPECTRA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HOLLYWOOD SPECTRA
HOLLYWOOD SPECTRA
97678736 not registered Live/Pending
Lutronic Corporation
2022-11-15

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