510(k) · Cleared
ClearedVisijet Hydrokeratome, Model 50
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visijet, Inc. · MYD Keratome, Water Jet
Cleared on Oct 20, 2000 as substantially equivalent to K983317 (Barron Precision Instruments, LLC, 1998) and 2 other predicates after a 567-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Oct 20, 2000
- Review
- 567 days
- Class
- Class I
- Product code
- MYD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K935342 (1994). 11 ancestors in all, the oldest K860001 (1986). No later device cites it as a predicate yet.
- Root · 4 generations backK935342 SCMD KeratomeS.C.M.D. Keratomes of Arizona · 1994
- 3 generations backK970377 Plancon Microlamellar Keratome (Single Piece Keratome Head with…Plancon Instruments · 1997
- 2 generations backK973294 Innovatome MicrokeratomeInnovative Optics, Inc. · 1997
- 1 generation backK983317 Barron Microkeratome System, Model B2000Barron Precision Instruments, LLC · 1998
- This deviceK991124 Visijet Hydrokeratome, Model 50Visijet, Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K935342 | SCMD Keratome | S.C.M.D. Keratomes of Arizona | 1994 | — |
| −3 | K970377 | Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories) | Plancon Instruments | 1997 | — |
| −2 | K973294 | Innovatome Microkeratome | Innovative Optics, Inc. | 1997 | — |
| −1 | K983317 | Barron Microkeratome System, Model B2000 | Barron Precision Instruments, LLC | 1998 | — |
| 0 (this device) | K991124 | Visijet Hydrokeratome, Model 50 | Visijet, Inc. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 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 MYD? 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 |
|---|---|---|---|
| * | K983317 | Barron Microkeratome System, Model B2000 Our OCR of the scanned summary read K973317, FDA’s number for Pasco Mic and Mic/ID Panels (Pasco Laboratories, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Barron Microkeratome System Model B2000”. | 1998 |
| * | K971078 | Hydrobrush (TM) KeratomeSummary page 2…B2000 510(k): K973317 62 VisiJet, Inc. ' March 29, 1999 VisiJet™ Hydrokeratome™ Premarket Notification Company: Medjet, Inc. Device: HydroBrush 510(k): K971078 Company: Hansa Research and Development, Inc. Device: Automatic Corneal Shaper (ACS) 510(k): 913697 4, A description of the devi… | 1998 |
| * | K913697 | Automatic Corneal ShaperSummary page 2…market Notification Company: Medjet, Inc. Device: HydroBrush 510(k): K971078 Company: Hansa Research and Development, Inc. Device: Automatic Corneal Shaper (ACS) 510(k): 913697 4, A description of the device that is the subject of the 510(k), including explanation of how the device functions, basic scien… | 1991 |
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 6 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- None of the 11 ancestors has a recall.
How does its category compare?
All MYD devicesMYD Keratome, Water Jet: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MYD
FDA has decided no MYD device since 2007.
Median 510(k) review, days · MYD
Too few MYD 510(k)s in any year since 2007 to give a median.
Recalls per year · MYD
No recall names MYD since 2007.
Adverse event reports per year · MYD
No MAUDE report names MYD since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VisiJet Hydrokeratome is indicated for use in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991124: Visijet Hydrokeratome, Model 50.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991124
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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