ELITA Femtosecond Laser System, ELITA Patient Interface
FDA 510(k) K223566 · Johnson & Johnson Surgical Vision, Inc.
510(k) numberK223566
Submission
- Device name
- ELITA Femtosecond Laser System, ELITA Patient Interface
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
Irvine, CA, US - Received
- November 29, 2022
- Decision date
- April 14, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OOE – Ophthalmic Femtosecond Laser
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4390
- Specialty
- Ophthalmic
Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery.
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|---|---|---|---|
| K252682 | LenSx Laser System (8065000944)OOE · Special | Alcon Laboratories, Inc. | 09/24/2025SE |
| K243896 | LenSx Laser System (8065998162)OOE · Traditional | Alcon Laboratories, Inc. | 04/28/2025SE |
| K223838 | Catalys Precision Laser SystemOOE · Traditional | Amo Manufacturing USA, LLC | 04/12/2023SE |
| K220259 | ALLY Adaptive Cataract Treatment SystemOOE · Traditional | Lensar, Inc. | 06/09/2022SE |
| K220516 | CATALYS Precision Laser systemOOE · Traditional | Amo Manufacturing USA, LLC | 05/17/2022SE |
| K213559 | FEMTO LDV Z8 Femtosecond Surgical LaserOOE · Traditional | Sie Ag,Surgical Instrument Engineering | 04/21/2022SE |
| K210701 | CATALYS Precision Laser SystemOOE · Special | Amo Manufacturing USA, LLC | 04/07/2021SE |
| K200724 | VICTUS Femtosecond Laser PlatformOOE · Traditional | Technolas Perfect Vision GmbH | 09/01/2020SE |
| K200056 | Catalys Precision Laser SystemOOE · Traditional | Amo Manufacturng USA, LLC | 05/18/2020SE |
| K182795 | LENSAR Laser System - fs 3D (LLS-fs 3D)OOE · Traditional | Lensar, Inc. | 12/21/2018SE |
More from Lensar, Inc.
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| K203060 | VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced…HQC · Traditional | 03/12/2021SE |
| K191949 | UNFOLDER Vitan InserterMSS · Abbreviated | 09/13/2019SE |
| K191933 | COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV…HQC · Special | 08/16/2019SE |
Questions and answers
When was ELITA Femtosecond Laser System, ELITA Patient Interface cleared by the FDA?
ELITA Femtosecond Laser System, ELITA Patient Interface (K223566) received a 510(k) decision of Substantially Equivalent on April 14, 2023, 136 days after the submission was received.
What is the product code of K223566?
The FDA product code is OOE – Ophthalmic Femtosecond Laser, a Class II (moderate risk) device regulated under 21 CFR 886.4390.