LENSAR Femtosecond Laser System
by Lensar, Inc.
510(k) K090633
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK090633 | Date13 May 2010 | StatusActive |
Official records
- FDA 510(k) database K090633
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Lensar Laser System
- 510(k) Number
- FDA product code
- OOE
- Device class
- Class II
- Regulation
- 21 CFR Part 886.4390
- Advisory committee
- Ophthalmic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The LENSAR Femtosecond Laser System is an ophthalmic femtosecond laser designed for refractive cataract surgery. It performs precise laser capsulotomies, lens fragmentation, limbal relaxing incisions, and corneal incisions, enabling multiple procedures in a single session with high accuracy.
This device is intended for use in clinical settings by ophthalmic surgeons and is supplied as a reusable medical instrument. It has received FDA 510(k) clearance under the Traditional pathway, classified as a Class II device (OOE). The system is not single-use and does not require sterile packaging, though proper cleaning and maintenance protocols must be followed. No specific MRI safety information is provided in the data.
From the manufacturer
The LENSAR Femtosecond Laser System is the leading laser technology for refractive cataract surgery, assisting eye surgeons in optimized refractive outcomes and superior astigmatism management.
The LENSAR Laser System The LENSAR ® Laser System is designed as a premier cataract treatment platform that adapts to you and your patients to guide superior clinical outcomes, promote faster visual recovery, and build confidence.
Similar devices
Other devices filed under FDA product code OOE (Ophthalmic Femtosecond Laser).
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- LENSX LASER SYSTEM by Alcon Lensx, Inc.
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- ELITA Femtosecond Laser System, ELITA Patient Interface by Johnson & Johnson Surgical Vision, Inc.
- LENSX 550 LASER SYSTEM by Lensx Lasers, Inc.
- LenSx Laser System (8065000944) by Alcon Laboratories, Inc.
- FEMTEC LASER SYSTEM FOR CAPSULOTOMY by Technolas Perfect Vision GmbH