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Saturn 5 Laser System

FDA UDI

Class II (US FDA UDI)

by Research Instruments , Ltd.

Identity

Trade Name
Saturn 5 Laser System FDA UDI
Generic Name
Assisted reproduction laser system FDA UDI
Device Name
Assisted Reproduction Laser FDA UDI
Model / Reference
Saturn 5 Active Olympus IX50-70 FDA UDI
Description
Assisted Reproduction Laser FDA UDI

Identifiers

Catalog Number
6-47-500-24 FDA UDI
Primary DI / UDI-DI
05060488043635 FDA UDI
510(k) Number
K141434 FDA UDI
FDA Product Code
MRX FDA UDI
GMDN Term
Assisted reproduction laser system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.6200 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: Assisted reproduction laser system

The Saturn 5 Laser System is a portable, mains electricity device designed for assisted reproduction. It excites a diode to emit a low-intensity laser beam to ablate the zona pellucida of an embryo during in vitro fertilization (IVF), typically as part of laser-assisted embryo hatching or embryo biopsy.

Similar devices

Also classified as Assisted reproduction laser system.

Cleared under the same submission

K141434 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Research Instruments , Ltd.

Sources (1)

  • FDA UDI 0165274a-a100-40d3-a2e0-b0a859cf4aa7 36 fields · synced Jul 23, 2026