510(k) · Cleared
ClearedCell Robotics ER: Yag Surgical Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cell Robotics, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jul 11, 1997 as substantially equivalent to K954013 (Schwartz Electro-Optics, Inc., 1996) after a 155-day review. Its family tree reaches back 1 generation to 1996. 16 later devices descend from it.
- Decided
- Jul 11, 1997
- Review
- 155 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954013 (1996). 16 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK954013 Trilase 2940 Erbium LaserSchwartz Electro-Optics, Inc. · 1996
- This deviceK970461 Cell Robotics ER: Yag Surgical LaserCell Robotics, Inc. · 1997
- Descendant · cites it directly · 13 of its ownK032599 Medical Laser Technologies, LLC MTL Erbium:Yag Laser SystemMedical Laser Technologies, LLC · 2003
- Descendant · 2 generations on · 2 of its ownK110897 Cortex CO2 / ER:Yag Laser SystemSandstone Medical Technologies, LLC · 2011
- Descendant · 2 generations on · 2 of its ownK110502 Triplex ER. Yag / ND: Yag SystemSandstone Medical Technologies, LLC · 2011
- Descendant · 2 generations on · 2 of its ownK110304 Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC · 2011
- Descendant · 2 generations on · 2 of its ownK063867 Cutera ER:Ysgg Laser HandpieceCutera, Inc. · 2007
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K032599Medical Laser Technologies, LLC MTL Erbium:Yag Laser SystemMedical Laser Technologies, LLC · 2003 · cites it directly13descendants
- K110897Cortex CO2 / ER:Yag Laser SystemSandstone Medical Technologies, LLC · 2011 · 2 generations on2descendants
- K110502Triplex ER. Yag / ND: Yag SystemSandstone Medical Technologies, LLC · 2011 · 2 generations on2descendants
- K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC · 2011 · 2 generations on2descendants
- K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc. · 2007 · 2 generations on2descendants
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) | K970461 | Cell Robotics ER: Yag Surgical Laser | Cell Robotics, Inc. | 1997 | — |
| +1 | K032599 | Medical Laser Technologies, LLC MTL Erbium:Yag Laser System | Medical Laser Technologies, LLC | 2003 | — |
| +2 | K110897 | Cortex CO2 / ER:Yag Laser System | Sandstone Medical Technologies, LLC | 2011 | — |
| +2 | K110502 | Triplex ER. Yag / ND: Yag System | Sandstone Medical Technologies, LLC | 2011 | — |
| +2 | K110304 | Apex ER. Yag / Ipl System | Sandstone Medical Technologies, LLC | 2011 | — |
| +2 | K063867 | Cutera ER:Ysgg Laser Handpiece | Cutera, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K954013 | Trilase 2940 Erbium LaserSummary page 1…Surgical Laser (to be determined) Er: YAG Pulsed Surgical Laser Instrument, Surgical, Powered, laser 79-GEX 21 CFR 878-48 Schwartz Electro-Optics TriLase2940 510(K) # K 954013 The Cell Robotics Er:YAG Surgical Laser is an Er:YAG laser producing laser emission at 2940nm. The laser consists of three inter… | 1996 |
What descends from it? (16)
See all 163 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?
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 Cell Robotics, Inc. unnamed Er:YAG Surgical laser is indicated for
use in small and large joint Arthroscopy, including microdiscectomies,
endoscopic procedures and general surgical procedures for cutting
(incision / excision), vaporizing and coagulation of soft tissues, including
skin, subcutaneous tissue, muscle, meniscus, mucous membrane, lymph
vessels and nodes, organs and glands.
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/K970461 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970461: Cell Robotics ER: Yag Surgical Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970461
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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