510(k) · Cleared
ClearedDA Vinci Femtosecond Surgical Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sie Ltd Surgical Instrument Engineering · GEX Powered Laser Surgical Instrument
Cleared on Mar 10, 2006 as substantially equivalent to K013941 (Intra Lase Corp., 2002) and 1 other predicate after an 84-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Mar 10, 2006
- Review
- 84 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K913697 (1991). 6 ancestors in all, the oldest K892058 (1989). No later device cites it as a predicate yet.
- Root · 4 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 3 generations backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- 2 generations backK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · Recalled
- 1 generation backK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · Recalled
- This deviceK053511 DA Vinci Femtosecond Surgical LaserSie Ltd Surgical Instrument Engineering · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −3 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| −2 | K993153 | Intralase 600C Laser Keratome | Intra Lase Corp. | 1999 | 1 |
| −1 | K013941 | Pulsion FS Laser Keratome | Intra Lase Corp. | 2002 | 1 |
| 0 (this device) | K053511 | DA Vinci Femtosecond Surgical Laser | Sie Ltd Surgical Instrument Engineering | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 2000 | 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 GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K013941 | Pulsion FS Laser KeratomeSummary page 5…The technical characteristics of the Da VinciTM Femtosecond Surgical Laser are substantially equivalent to those of the Pulsion FS Laser of IntraLase Corp. cleared under K013941. The intended use and the indication for use are identical to those of the Amadeus Microkeratome cleared under K993190.… | 2002 |
| * | K993190 | Advanced Computer Controlled Microkeratome-Accm, Model Surgical Instrument Systems (Sis)Summary page 4…he Base Station. Design, materials, cleaning and sterilization procedures of the Suction Ring are identical to the SR used with the Amadeus Microkeratome cleared under K993190. Distance Foil The foil is an adhesive film made of medical grade plastic.. Vacuum Tube with Strainer The sterile vacuum tube c… | 2000 |
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 15 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 6 other devices also cite its predicate K013941.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The Da VinciTM Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053511 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053511: DA Vinci Femtosecond Surgical Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053511
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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