Device class
Class II
Regulation 884.6200
Total clearances
3
2020-03-25 → 2026-06-17
Definition
What is System, Assisted Reproduction Laser
This system is inteded to be used to drill a small tangential hole in or to thin the zona pellucida of the embryo in selected in vitro fertilization patients with otherwise poor prognois for successful pregnancy outcome, such as advanced maternal age, prior failed in vitro fertilization procedures, cryopreserved embryos, or abnormal zona pellucida morphology.
Classification details
Medical specialty
Obstetrics/Gynecology
Regulation number
884.6200
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Hua Yue Medical Technology Co., Ltd. |
1 |
1 |
2026-06-17 |
|
Hamilton Thorne, Inc. |
1 |
0 |
2021-07-02 |
|
Vitrolife GmbH |
1 |
0 |
2020-03-25 |
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.
| Code | Type | Description | Confidence | Rationale |
| 58346 |
CPT
|
— |
Medium
|
In vitro fertilization related procedure code; laser-assisted hatching sometimes billed separately or with IVF |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-06-17 |
K253333 |
Hua Yue Medical Technology Co., Ltd.
|
Assisted Reproduction Laser System (Model ILS-400M) |
| 2021-07-02 |
K202241 |
Hamilton Thorne, Inc.
|
LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) |
| 2020-03-25 |
K192008 |
Vitrolife GmbH
|
LaserShot M, NaviLase |