510(k) · Cleared
ClearedSchwartz Electro-Optics, Inc. CLR 2940/Erbium Crystalase (Formerly Trilase 2940 Erbium Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schwartz Electro-Optics, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jul 9, 1997 as substantially equivalent to K954013 (Schwartz Electro-Optics, Inc., 1996) after an 84-day review. Its family tree reaches back 1 generation to 1996. 57 later devices descend from it.
- Decided
- Jul 9, 1997
- Review
- 84 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954013 (1996). 57 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK954013 Trilase 2940 Erbium LaserSchwartz Electro-Optics, Inc. · 1996
- This deviceK971404 Schwartz Electro-Optics, Inc. CLR 2940/Erbium Crystalase (Formerly…Schwartz Electro-Optics, Inc. · 1997
- Descendant · cites it directly · 56 of its ownK981438 Dornier Medilas EDornier Surgical Products, Inc. · 1998
- Descendant · 2 generations on · 53 of its ownK050317 Burane XLWavelight Laser Technologie AG · 2005
- Descendant · 2 generations on · 52 of its ownK052806 BuraneWavelight Laser Technologie AG · 2005
- 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 57 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 57 · See all- K981438Dornier Medilas EDornier Surgical Products, Inc. · 1998 · cites it directly56descendants
- K050317Burane XLWavelight Laser Technologie AG · 2005 · 2 generations on53descendants
- K052806BuraneWavelight Laser Technologie AG · 2005 · 2 generations on52descendants
- 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 |
|---|---|---|---|---|---|
| −1 | K954013 | Trilase 2940 Erbium Laser | Schwartz Electro-Optics, Inc. | 1996 | — |
| 0 (this device) | K971404 | Schwartz Electro-Optics, Inc. CLR 2940/Erbium Crystalase (Formerly Trilase… | Schwartz Electro-Optics, Inc. | 1997 | — |
| +1 | K981438 | Dornier Medilas E | Dornier Surgical Products, Inc. | 1998 | — |
| +2 | K050317 | Burane XL | Wavelight Laser Technologie AG | 2005 | — |
| +2 | K052806 | Burane | Wavelight Laser Technologie AG | 2005 | — |
| +3 | K082947 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| +4 | K094052 | Lensx 550 Laser System. Model 550 | Lensx Lasers, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2005 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 6 | 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 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 |
|---|---|---|---|
| * | K954013 | Trilase 2940 Erbium LaserSummary page 5…EO550FS <7 7P LS Indication for Use Schwartz Electro-Optics, Inc. is not requesting any additional indications or changing the indications as ) previously cleared in K954013 received 1/31/96. As previously cleared, the Schwartz Electro-Optics, Inc. CLR 2940 will be indicated for use in small and large… | 1996 |
| * | — | Premier Centauri Erbium Named without a submission number |
What descends from it? (57)
See all 571 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981438 | Dornier Medilas E | 1998 | 56 |
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?
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?
As previously cleared, the Schwartz Electro-Optics, Inc. CLR 2940 will be indicated for use in small and large joint Arthroscopy, including laparoscopic procedures, general and all surgical procedures for cutting (incision/excision), vaporizing, ablating and coagulating soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, striated and…
Read the full statement (101 words)
As previously cleared, the Schwartz Electro-Optics, Inc. CLR 2940 will be indicated for use in small and large joint Arthroscopy, including laparoscopic procedures, general and all surgical procedures for cutting (incision/excision), vaporizing, ablating and coagulating soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
Specialties are:
* General Surgery
Plastic Surgery,
Podiatry
Urology
Gynecology
Pulmionary Surgery
* Dermatology
* Gastroenterology
* Ophthalmology
* ENT
Thoracic Surgery
Cral and Maxiliofacial Surgery
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/K971404 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971404: Schwartz Electro-Optics, Inc. CLR 2940/Erbium Crystalase (Formerly Trilase 2940 Erbium Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971404
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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