510(k) · Cleared
Recalled · Class II · 2013Femto LDV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sie Ag,Surgical Instument Engineering · HQF Laser, Ophthalmic
Cleared on Mar 16, 2012 after a 233-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 14 later devices descend from it. It has been recalled once.
- Decided
- Mar 16, 2012
- Review
- 233 days
- Class
- Class II
- Product code
- HQF
- Recalls
- 1
- Predicates
- 0
14 later devices descend from it, 1 citing it directly.
- This deviceK112154 Femto LDVSie Ag,Surgical Instument Engineering · 2012
- Descendant · cites it directly · 13 of its ownK131207 Femto LDV (TM) Z-Generation Femtosecond Surgical LaserSurgical Instrument Engineering AG · 2013 · Recalled
- Descendant · 2 generations on · 8 of its ownK141476 Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc. · 2014
- Descendant · 2 generations on · 5 of its ownK141852 Ifs Advanced Femtosecond Laser SystemAmo Manufacturing USA, LLC · 2015
- Descendant · 3 generations on · 3 of its ownK173346 LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2018
- Descendant · 4 generations on · 2 of its ownK181430 LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2018
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K131207Femto LDV (TM) Z-Generation Femtosecond Surgical LaserSurgical Instrument Engineering AG · 2013 · cites it directly13descendants
- K141476Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc. · 2014 · 2 generations on8descendants
- K141852Ifs Advanced Femtosecond Laser SystemAmo Manufacturing USA, LLC · 2015 · 2 generations on5descendants
- K173346LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2018 · 3 generations on3descendants
- K181430LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2018 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K112154 | Femto LDV | Sie Ag,Surgical Instument Engineering | 2012 | — |
| +1 | K131207 | Femto LDV (TM) Z-Generation Femtosecond Surgical Laser | Surgical Instrument Engineering AG | 2013 | 1 |
| +2 | K141476 | Wavelight FS200 Laser System | Alcon Research, Ltd. Dba Alcon Laboratories, Inc. | 2014 | — |
| +2 | K141852 | Ifs Advanced Femtosecond Laser System | Amo Manufacturing USA, LLC | 2015 | — |
| +3 | K173346 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2018 | — |
| +4 | K181430 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 5 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HQF? 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 HQF device
- #1 K251772 Navilas Laser System 577sl (156691)score 13.6 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131207 | Femto LDV (TM) Z-Generation Femtosecond Surgical Laser | 2013 | 13 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 16, 2013 | Class II | Z-0811-2014 | Component design/selection | A defect in the controller board can lead to the condenser to the video monitor becoming too warm. This could potentially cause the video monitor to shut off. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K131207 (Surgical Instrument Engineering AG, 2013) has gone furthest, with 13 descendants of its own.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HQF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQF
264in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQF
106in 2025
MAUDE reports naming product code HQF, 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 | 4 | 198 | 2 | 60 |
| 2008 | 3 | 28 | 1 | 34 |
| 2009 | 7 | 115 | 2 | 33 |
| 2010 | 2 | — | 3 | 43 |
| 2011 | 4 | 128 | 5 | 26 |
| 2012 | 5 | 179 | 1 | 41 |
| 2013 | 6 | 225 | 2 | 39 |
| 2014 | 3 | 215 | 4 | 58 |
| 2015 | 4 | 295 | 0 | 80 |
| 2016 | 3 | 271 | 0 | 108 |
| 2017 | 3 | 189 | 0 | 77 |
| 2018 | 1 | — | 0 | 82 |
| 2019 | 4 | 107 | 0 | 66 |
| 2020 | 4 | 53 | 0 | 72 |
| 2021 | 1 | — | 0 | 100 |
| 2022 | 7 | 86 | 0 | 111 |
| 2023 | 5 | 155 | 0 | 92 |
| 2024 | 3 | 167 | 0 | 75 |
| 2025 | 3 | 264 | 1 | 106 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal surface. The FEMTO LDV Z4 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel…
Read the full statement (179 words)
The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal surface.
The FEMTO LDV Z4 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that does not enclose a volume of the cornea.
The FEMTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty, penetrating keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect the corneal surface that may enclose a volume of the cornea.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K112154 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112154: Femto LDV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112154
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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