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MICRORUPTOR 6

Meridian AG

Country / region:Switzerland (CH)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Meridian AG
Switzerland (CH)

Product code

GEX
21 CFR 878.4810

Predicate devices

0
Cited in this 510(k)

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K160677
Device name
MICRORUPTOR 6
Company
Meridian AG
Country / region
Switzerland(CH)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2016-03-10
Decision date
2017-05-19
Submission type
Traditional
Technology type
Nd:YAG(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The Microruptor 6 Nd:YAG Laser is indicated for:
- posterior capsulotomy,
- pupillary membranectomy
- peripheral iridotomy

Intended Use

The Microruptor 6 Nd:YAG Laser is indicated for:
- posterior capsulotomy,
- pupillary membranectomy
- peripheral iridotomy

Summary parsed at:2026-06-01 05:58:41 UTC

Predicate devices

0

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