FDA UDI
In Commercial Distribution
🇺🇸 United States
LLS/ALLY
DI: 00867744000174
·
Model: 70-00046-001
·
LENSAR, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- LLS/ALLY
- Primary DI
- 00867744000174
- Version / Model
- 70-00046-001
- Catalog Number
- 70-00046-001
- Company Name
- LENSAR, Inc.
- Labeler DUNS
- 004071212
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-13
- Public Version
- 1
- Public Version Date
- 2026-04-21
- Public Version Status
- New
- Public Device Record Key
- 8e86312a-a45c-4dfd-84f6-e62b25c5477b
Device Description
Patient Interface Device-Round
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 65747 | Ophthalmic laser system eyeball positioning suction cup | A non-powered device intended to orient and fix the eyeball in a desired position relative to an ophthalmic laser system beam guide during ophthalmic laser surgery. It is designed as a laser-interfacing suction cup intended to contact and stabilize the eyeball via suction controlled by the laser system; it may also include a treatment contact lens. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30867744000175 | GS1 | Shelf Box | 10 | In Commercial Distribution | |
| Primary | 00867744000174 | GS1 | ||||
| Package | 10867744000171 | GS1 | Shelf Box | 20 | In Commercial Distribution | |
| Package | 20867744000178 | GS1 | Shipping Carton | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- 888-536-7271
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -29 – 59 Degrees Celsius