510(k) · Cleared
ClearedPlancon Microlamellar Keratome Evolution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plancon Instruments · HNO Keratome, Ac-Powered
Cleared on Apr 15, 1998 as substantially equivalent to K960395 (Plancon Instruments, 1996) and 1 other predicate after a 35-day review. Its family tree reaches back 2 generations to 1994. 66 later devices descend from it.
- Decided
- Apr 15, 1998
- Review
- 35 days
- Class
- Class I
- Product code
- HNO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K935342 (1994). 3 ancestors in all. 66 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK935342 SCMD KeratomeS.C.M.D. Keratomes of Arizona · 1994
- 1 generation backK970377 Plancon Microlamellar Keratome (Single Piece Keratome Head with…Plancon Instruments · 1997
- This deviceK980924 Plancon Microlamellar Keratome EvolutionPlancon Instruments · 1998
- Descendant · cites it directly · 63 of its ownK981741 Carriazo Barraquer MicrokeratomeMoria, Inc. · 1998
- Descendant · cites it directly · 58 of its ownK032910 Carriazo PendularSchwind Eye-Tech-Solutions GmbH & Co. KG · 2004
- Descendant · 2 generations on · 56 of its ownK073404 Ifs Laser SystemIntra Lase Corp. · 2008
- Descendant · 3 generations on · 51 of its ownK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- Descendant · 4 generations on · 47 of its ownK094052 Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010
Showing 5 of 66 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 66 · See all- K981741Carriazo Barraquer MicrokeratomeMoria, Inc. · 1998 · cites it directly63descendants
- K032910Carriazo PendularSchwind Eye-Tech-Solutions GmbH & Co. KG · 2004 · cites it directly58descendants
- K073404Ifs Laser SystemIntra Lase Corp. · 2008 · 2 generations on56descendants
- K082947Lensx 550 Laser SystemLensx Lasers, Inc. · 2009 · 3 generations on51descendants
- K094052Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010 · 4 generations on47descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935342 | SCMD Keratome | S.C.M.D. Keratomes of Arizona | 1994 | — |
| −1 | K970377 | Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories) | Plancon Instruments | 1997 | — |
| 0 (this device) | K980924 | Plancon Microlamellar Keratome Evolution | Plancon Instruments | 1998 | — |
| +1 | K981741 | Carriazo Barraquer Microkeratome | Moria, Inc. | 1998 | — |
| +1 | K032910 | Carriazo Pendular | Schwind Eye-Tech-Solutions GmbH & Co. KG | 2004 | — |
| +2 | K073404 | Ifs Laser System | Intra Lase Corp. | 2008 | — |
| +3 | K082947 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| +4 | K094052 | Lensx 550 Laser System. Model 550 | Lensx Lasers, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 4 | 0 |
| 2012 | 8 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 6 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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 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? (2)
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 |
|---|---|---|---|
| * | K960395 | Plancon Mircolamellar KeratomeSummary page 2…sembling (problem cancelled with new device), - Cleaning, - Sterilizing. 4) Problems related to the surgical procedure. Same as filed submitted for 510 K document number K 960395 and K 970377. Printed name of person required to submit 510 (k) : Alain DUPRAT Signature of person required to submit 510 (k) : T… | 1996 |
| * | K970377 | Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories)Summary page 2…blem cancelled with new device), - Cleaning, - Sterilizing. 4) Problems related to the surgical procedure. Same as filed submitted for 510 K document number K 960395 and K 970377. Printed name of person required to submit 510 (k) : Alain DUPRAT Signature of person required to submit 510 (k) : Title of perso… | 1997 |
What descends from it? (66)
See all 664 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K981741 (Moria, Inc., 1998) has gone furthest, with 63 descendants of its own.
- 2 other devices also cite its predicate K960395.
How does its category compare?
All HNO devicesHNO Keratome, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
This device is intended for use in refractive surgery, to perform microlamellar keratoplasty or keratomileusis in-situ for the correction of myopia and hyperopla
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/K980924 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980924: Plancon Microlamellar Keratome Evolution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980924
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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