510(k) · Cleared
ClearedCB Erbium/2.94(TM) ER:Yag Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Continuum Biomedical, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jun 11, 1997 after a 90-day review. The FDA summary names its predicate without a number. 304 later devices descend from it.
- Decided
- Jun 11, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
304 later devices descend from it, 4 citing it directly.
- This deviceK970934 CB Erbium/2.94(TM) ER:Yag LaserContinuum Biomedical, Inc. · 1997
- Descendant · cites it directly · 241 of its ownK974641 Futurelase 3000/3002 Erbium Laser SystemBuckman Co., Inc. · 1998
- Descendant · 2 generations on · 240 of its ownK021508 Opusduo EC Dental Laser SystemOpusdent, Ltd. · 2002
- Descendant · 3 generations on · 226 of its ownK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004
- Descendant · 4 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- Descendant · 5 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
Showing 5 of 304 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 304 · See all- K974641Futurelase 3000/3002 Erbium Laser SystemBuckman Co., Inc. · 1998 · cites it directly241descendants
- K021508Opusduo EC Dental Laser SystemOpusdent, Ltd. · 2002 · 2 generations on240descendants
- K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004 · 3 generations on226descendants
- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 4 generations on221descendants
- K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 5 generations on202descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970934 | CB Erbium/2.94(TM) ER:Yag Laser | Continuum Biomedical, Inc. | 1997 | — |
| +1 | K974641 | Futurelase 3000/3002 Erbium Laser System | Buckman Co., Inc. | 1998 | — |
| +2 | K021508 | Opusduo EC Dental Laser System | Opusdent, Ltd. | 2002 | — |
| +3 | K040270 | Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum | Lumenis, Ltd. | 2004 | — |
| +4 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| +5 | K073063 | 15W Ceralas D 1470NM Diode Laser | Biolitec, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 11 | 0 |
| 2009 | 6 | 0 |
| 2010 | 11 | 0 |
| 2011 | 13 | 0 |
| 2012 | 5 | 0 |
| 2013 | 12 | 0 |
| 2014 | 12 | 0 |
| 2015 | 13 | 0 |
| 2016 | 15 | 0 |
| 2017 | 10 | 0 |
| 2018 | 15 | 0 |
| 2019 | 7 | 0 |
| 2020 | 19 | 0 |
| 2021 | 12 | 0 |
| 2022 | 26 | 0 |
| 2023 | 18 | 0 |
| 2024 | 30 | 0 |
| 2025 | 37 | 0 |
| 2026 | 16 | 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 |
|---|---|---|---|
| * | — | Schwartz Electro-Optics TriLase 2940 Named without a submission number | |
| * | — | Coherent UltraPulse CO2 Laser Named without a submission number |
What descends from it? (304)
See all 3044 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?
- Of its descendants, K974641 (Buckman Co., Inc., 1998) has gone furthest, with 241 descendants of its own.
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?
For skin resurfacing in the treatment of wrinkles
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/K970934 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970934: CB Erbium/2.94(TM) ER:Yag Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970934
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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