AccessGUDID - DEVICE: SLT II (08057017760009)

GUDID

Device Identifier (DI) Information

Brand Name: SLT II
Version or Model: M094E1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M094E1
Company Name: EL.EN. SPA

Primary DI Number: 08057017760009
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 436887608 *Terms of Use

Device Description: The Cynosure SLT II workstation has a solid state Nd:YAG laser capable of emitting laser radiation in three wavelenghts and includes a wide range of different delivery system, handpieces, fibers, cannulas and other accessories.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36170	General/multiple surgical solid-state laser system	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OYW	Laser, Cellulite Appearance

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091537	000
K102541	000
K123407	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 5 and 50 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between 10 and 30 Degrees Celsius
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 166d343c-08f6-422f-a2aa-ff3163238694
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 13, 2016