AccessGUDID - DEVICE: FS LASER SYSTEM (05050474573451)

GUDID

Device Identifier (DI) Information

Brand Name: FS LASER SYSTEM
Version or Model: 20005D
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20005D
Company Name: JOHNSON & JOHNSON SURGICAL VISION, INC.

Primary DI Number: 05050474573451
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010130626 *Terms of Use

Device Description: FS LASER SYS M2, IEK CAP, 120V, 60HZ

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?
57995	Femtosecond ophthalmic 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 ocular resections and incisions (cataract incisions, arcuate corneal/scleral cuts/tunnels, anterior capsulotomy, phacofragmentations, corneal flaps, lamellar/perforating keratoplasty). The system includes a beam delivery device, imaging device, computer, software and controls; it cuts by micro-photodisruption of tissue created by focused ultra-short [femtosecond (FS)] pulses; it does not include fundus imaging technology and the therapeutic laser is not frequency-doubled.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNO	KERATOME, AC-POWERED
GEX	Powered laser surgical instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c446439b-1422-4886-865a-ac3c512cc5d3
Public Version Date: February 26, 2020
Public Version Number: 4
DI Record Publish Date: September 02, 2016