Chrysalis Intelligence · Product Codes · OOE

OOE · Ophthalmic Femtosecond Laser

Ophthalmic · 10 clearances · 7 unique sponsors

Device class
Class II
Regulation 886.4390
Total clearances
10
2020-05-18 → 2025-09-24
Last 12 months
1
Unique sponsors
7
Definition

What is Ophthalmic Femtosecond Laser

Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery.
Medical specialty
Ophthalmic
Review panel
OP
Regulation number
886.4390
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Amo Manufacturing USA, LLC 3 0 2023-04-12
Alcon Laboratories, Inc. 2 1 2025-09-24
Lensar, Inc. 1 0 2022-06-09
Technolas Perfect Vision GmbH 1 0 2020-09-01
Sie Ag,Surgical Instrument Engineering 1 0 2022-04-21
Amo Manufacturng USA, LLC 1 0 2020-05-18
Johnson & Johnson Surgical Vision, Inc. 1 0 2023-04-14
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
66821 CPT High Extraction, lens material by phacoemulsification; with implantation of intraocular lens
55650 CPT Medium Ultrasound guidance for placement of cryosurgical probe (includes transrectal ultrasound guidance)
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-09-24 K252682 Alcon Laboratories, Inc. LenSx Laser System (8065000944)
2025-04-28 K243896 Alcon Laboratories, Inc. LenSx Laser System (8065998162)
2023-04-14 K223566 Johnson & Johnson Surgical Vision, Inc. ELITA™ Femtosecond Laser System, ELITA™ Patient Interface
2023-04-12 K223838 Amo Manufacturing USA, LLC Catalys™ Precision Laser System
2022-06-09 K220259 Lensar, Inc. ALLY Adaptive Cataract Treatment System
2022-05-17 K220516 Amo Manufacturing USA, LLC CATALYS Precision Laser system
2022-04-21 K213559 Sie Ag,Surgical Instrument Engineering FEMTO LDV Z8 Femtosecond Surgical Laser
2021-04-07 K210701 Amo Manufacturing USA, LLC CATALYS Precision Laser System
2020-09-01 K200724 Technolas Perfect Vision GmbH VICTUS Femtosecond Laser Platform
2020-05-18 K200056 Amo Manufacturng USA, LLC Catalys Precision Laser System