510(k) · Cleared
ClearedVisuMax Femtosecond Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, Inc. · HNO Keratome, Ac-Powered
Cleared on Apr 13, 2018 as substantially equivalent to K100253 (Carl Zeiss Meditec, AG, 2010) and 2 other predicates after a 168-day review. Its family tree reaches back 13 generations to 1991.
- Decided
- Apr 13, 2018
- Review
- 168 days
- Class
- Class I
- Product code
- HNO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K913697 (1991). 70 ancestors in all, the oldest K822112 (1982). No later device cites it as a predicate yet.
- Root · 13 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 9 generations between
- 3 generations backK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010
- 2 generations backK113151 Ifs Laser SystemAbbott Medical Optics, Inc. · 2012
- 1 generation backK141476 Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc. · 2014
- This deviceK173371 VisuMax Femtosecond LaserCarl Zeiss Meditec, Inc. · 2018
Show all 13 generations
- Root · 13 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 12 generations backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- 11 generations backK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · Recalled
- 10 generations backK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · Recalled
- 9 generations backK031960 Intralase FS LaserIntra Lase Corp. · 2003 · Recalled
- 8 generations backK060372 Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006
- 7 generations backK063682 Intralase Fusion LaserIntra Lase Corp. · 2007
- 6 generations backK073404 Ifs Laser SystemIntra Lase Corp. · 2008
- 5 generations backK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- 4 generations backK092647 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- 3 generations backK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010
- 2 generations backK113151 Ifs Laser SystemAbbott Medical Optics, Inc. · 2012
- 1 generation backK141476 Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc. · 2014
- This deviceK173371 VisuMax Femtosecond LaserCarl Zeiss Meditec, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −12 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| −11 | K993153 | Intralase 600C Laser Keratome | Intra Lase Corp. | 1999 | 1 |
| −10 | K013941 | Pulsion FS Laser Keratome | Intra Lase Corp. | 2002 | 1 |
| −9 | K031960 | Intralase FS Laser | Intra Lase Corp. | 2003 | 3 |
| −8 | K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 | Intra Lase Corp. | 2006 | — |
| −7 | K063682 | Intralase Fusion Laser | Intra Lase Corp. | 2007 | — |
| −6 | K073404 | Ifs Laser System | Intra Lase Corp. | 2008 | — |
| −5 | K082947 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| −4 | K092647 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| −3 | K101626 | Lensx Laser System | Lensx Lasers, Inc. | 2010 | — |
| −2 | K113151 | Ifs Laser System | Abbott Medical Optics, Inc. | 2012 | — |
| −1 | K141476 | Wavelight FS200 Laser System | Alcon Research, Ltd. Dba Alcon Laboratories, Inc. | 2014 | — |
| 0 (this device) | K173371 | VisuMax Femtosecond Laser | Carl Zeiss Meditec, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 3 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 6 | 0 |
| 1998 | 7 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2010 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HNO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K100253 | Visumax Laser KeratomeSummary page 4…E DEVICE(S) PREDICATE DEVICE MANUFACTURER 510(K) CLEARANCE VisuMax Laser Keratome Carl Zeiss Meditec K100253 WaveLight FS200 Alcon Novartis K141476 IntraLase iFS Laser Abbott M… | 2010 |
| * | K141476 | Wavelight FS200 Laser SystemSummary page 4…10(K) CLEARANCE VisuMax Laser Keratome Carl Zeiss Meditec K100253 WaveLight FS200 Alcon Novartis K141476 IntraLase iFS Laser Abbott Medical Optics K141852 DEVICE DESCRIPTION The VisuMax Femtosecond Lase… | 2014 |
| * | K141852 | Ifs Advanced Femtosecond Laser SystemSummary page 4…K100253 WaveLight FS200 Alcon Novartis K141476 IntraLase iFS Laser Abbott Medical Optics K141852 DEVICE DESCRIPTION The VisuMax Femtosecond Laser is an ophthalmic surgical femtosecond laser intended for use in patients requir… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 13 of the 70 ancestors have a recall of any class.
- 1 other device also cites its predicate K100253.
How does its category compare?
All HNO devicesHNO Keratome, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · HNO
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · HNO
Too few HNO 510(k)s in any year since 2007 to give a median.
Recalls per year · HNO
4in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HNO
7in 2024
MAUDE reports naming product code HNO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 2 | 32 |
| 2008 | 1 | — | 2 | 31 |
| 2009 | 1 | — | 0 | 85 |
| 2010 | 0 | — | 0 | 84 |
| 2011 | 0 | — | 4 | 90 |
| 2012 | 0 | — | 0 | 100 |
| 2013 | 0 | — | 0 | 353 |
| 2014 | 0 | — | 0 | 452 |
| 2015 | 0 | — | 0 | 966 |
| 2016 | 0 | — | 0 | 1,397 |
| 2017 | 1 | — | 0 | 2,112 |
| 2018 | 1 | — | 0 | 2,265 |
| 2019 | 0 | — | 0 | 816 |
| 2020 | 0 | — | 0 | 405 |
| 2021 | 0 | — | 0 | 72 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VisuMax Femtosecond Laser is cleared for the following indications for use:
• In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea;
• In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea;
• In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty;
• In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting;
• In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173371 · printed Nov 4, 2026
Cite this page
510(k) Report. “K173371: VisuMax Femtosecond Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K173371
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026