510(k) · Cleared
Recalled · Class II · 2014Femto LDV (TM) Z-Generation Femtosecond Surgical Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Instrument Engineering AG · HQF Laser, Ophthalmic
Cleared on Oct 9, 2013 as substantially equivalent to K112154 (Sie Ag,Surgical Instument Engineering, 2012) after a 163-day review. Its family tree reaches back 1 generation to 2012. 13 later devices descend from it. It has been recalled once.
- Decided
- Oct 9, 2013
- Review
- 163 days
- Class
- Class II
- Product code
- HQF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K112154 (2012). 13 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK112154 Femto LDVSie Ag,Surgical Instument Engineering · 2012 · Recalled
- This deviceK131207 Femto LDV (TM) Z-Generation Femtosecond Surgical LaserSurgical Instrument Engineering AG · 2013
- Descendant · cites it directly · 8 of its ownK141476 Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc. · 2014
- Descendant · cites it directly · 5 of its ownK141852 Ifs Advanced Femtosecond Laser SystemAmo Manufacturing USA, LLC · 2015
- Descendant · 2 generations on · 3 of its ownK173346 LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2018
- Descendant · 3 generations on · 2 of its ownK181430 LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2018
- Descendant · 2 generations on · 2 of its ownK173660 LenSx Laser SystemAlcon Laboratories, Inc. · 2018
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K141476Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc. · 2014 · cites it directly8descendants
- K141852Ifs Advanced Femtosecond Laser SystemAmo Manufacturing USA, LLC · 2015 · cites it directly5descendants
- K173346LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2018 · 2 generations on3descendants
- K181430LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2018 · 3 generations on2descendants
- K173660LenSx Laser SystemAlcon Laboratories, Inc. · 2018 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K112154 | Femto LDV | Sie Ag,Surgical Instument Engineering | 2012 | 1 |
| 0 (this device) | K131207 | Femto LDV (TM) Z-Generation Femtosecond Surgical Laser | Surgical Instrument Engineering AG | 2013 | — |
| +1 | K141476 | Wavelight FS200 Laser System | Alcon Research, Ltd. Dba Alcon Laboratories, Inc. | 2014 | — |
| +1 | K141852 | Ifs Advanced Femtosecond Laser System | Amo Manufacturing USA, LLC | 2015 | — |
| +2 | K173346 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2018 | — |
| +3 | K181430 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2018 | — |
| +2 | K173660 | LenSx Laser System | Alcon Laboratories, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 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? (1)
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 |
|---|---|---|---|
| * | K112154 | Femto LDVSummary page 1…ALLY MARKETED DEVICE OR DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS BEING CLAIMED: 510(k) # Trade Name Manufacturer K112154 FEMTO LDV Z-Generation Femntosecond Surgical Laser SIE AG, Surgical… | 2012 |
What descends from it? (13)
See all 133 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 18, 2014 | Class II | Z-0988-2015 | Labeling False and Misleading | The devices were not shipped with the Starter Kits. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K141476 (Alcon Research, Ltd. Dba Alcon Laboratories, Inc., 2014) has gone furthest, with 8 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. 2013, 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 FEMVTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for the use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, packet 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 to the corneal surface. In addition, the…
Read the full statement (109 words)
The FEMVTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for the use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, packet 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 to the corneal surface.
In addition, the FEMVTO LDV Z6 Surgical Laser is intended far use in patients undergoing cataract surgery for the creation of single-plane, multi-plane, partial thickness and full thickness cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131207: Femto LDV (TM) Z-Generation 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/K131207
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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