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LENSAR LLS-fs 3D

FDA UDI

Class II (US FDA UDI)

by Lensar

Identity

Trade Name
LENSAR LLS-fs 3D FDA UDI
Generic Name
Femtosecond ophthalmic solid-state laser system FDA UDI
Model / Reference
70-00013-001 FDA UDI

Identifiers

Primary DI / UDI-DI
00867744000112 FDA UDI
510(k) Number
K143010 FDA UDI
K152453 FDA UDI
FDA Product Code
HQC FDA UDI
OOE FDA UDI
GMDN Term
Femtosecond ophthalmic solid-state laser system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.4670 FDA UDI
886.4390 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Femtosecond ophthalmic solid-state laser system

LENSAR LLS-fs 3D by Lensar — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Femtosecond ophthalmic solid-state laser system.

Cleared under the same submission

K143010 also covers:

K152453 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lensar

Sources (1)

  • FDA UDI 27ec264d-65fe-496c-a06a-7fb6544b9449 35 fields · synced May 30, 2026