Manufacturer
Meridian AGMICRORUPTOR 6
Country / Region:Switzerland (CH)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
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
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0No later 510(k)s cite this device yet
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