FDA UDI
In Commercial Distribution
🇺🇸 United States
CATALYS SYSTEM
DI: 05050474617186
·
Model: CAT PREC LSR SYS
·
JOHNSON & JOHNSON SURGICAL VISION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CATALYS SYSTEM
- Primary DI
- 05050474617186
- Version / Model
- CAT PREC LSR SYS
- Catalog Number
- 0160-6020
- Company Name
- JOHNSON & JOHNSON SURGICAL VISION, INC.
- Labeler DUNS
- 010130626
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-19
- Public Version
- 6
- Public Version Date
- 2026-03-04
- Public Version Status
- Update
- Public Device Record Key
- 2219d84c-1608-44b4-9ed5-0d589ef3b462
Device Description
CATALYS SYSTEM, US, NO BED
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OOE | Ophthalmic femtosecond laser | Ophthalmic | 886.4390 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05050474617186 | GS1 |
Customer Contacts
- Phone
- +1(800)511-0911
- [email protected]