510(k) · Cleared
ClearedCB Diode/532 Laser System
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 Mar 29, 1996 as substantially equivalent to K951034 (Laserscope, 1995) and 1 other predicate after a 156-day review. Its family tree reaches back 1 generation to 1994. 308 later devices descend from it.
- Decided
- Mar 29, 1996
- Review
- 156 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K933880 (1994). 2 ancestors in all. 308 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
- This deviceK954905 CB Diode/532 Laser SystemContinuum Biomedical, Inc. · 1996
- Descendant · cites it directly · 307 of its ownK964074 Diolite 532Iriderm Div. · 1997
- Descendant · 2 generations on · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- Descendant · 3 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- Descendant · 3 generations on · 92 of its ownK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 92 of its ownK020071 Viridis Derma LaserQuantel Medical · 2002
Showing 5 of 308 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 308 · See all- K964074Diolite 532Iriderm Div. · 1997 · cites it directly307descendants
- K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · 2 generations on198descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 3 generations on111descendants
- K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · 3 generations on92descendants
- K020071Viridis Derma LaserQuantel Medical · 2002 · 2 generations on92descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933880 | SL Series Surgical Laser Systems | Laserscope | 1994 | — |
| 0 (this device) | K954905 | CB Diode/532 Laser System | Continuum Biomedical, Inc. | 1996 | — |
| +1 | K964074 | Diolite 532 | Iriderm Div. | 1997 | — |
| +2 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| +3 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| +3 | K103118 | Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor | Hoya Photonics, Inc. | 2010 | 1 |
| +2 | K020071 | Viridis Derma Laser | Quantel Medical | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 6 | 0 |
| 2011 | 7 | 0 |
| 2012 | 4 | 0 |
| 2013 | 11 | 0 |
| 2014 | 16 | 0 |
| 2015 | 13 | 0 |
| 2016 | 17 | 0 |
| 2017 | 17 | 0 |
| 2018 | 15 | 0 |
| 2019 | 15 | 0 |
| 2020 | 18 | 0 |
| 2021 | 16 | 0 |
| 2022 | 32 | 0 |
| 2023 | 15 | 0 |
| 2024 | 33 | 0 |
| 2025 | 34 | 0 |
| 2026 | 23 | 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 |
|---|---|---|---|
| * | K951034 | Aura Laser SystemSummary page 1…President October 24, 1995 CB Diode/532 Laser System Dermatology laser system Instrument, surgical, powered, laser 79-GEX 21 CFR 878.48 LaserScope Aura Laser System (K951034) LaserScope SL Series 12 Watt KTP (K933880) The CB Diode/532 consists of the laser enclosure and the fiber optic delivery system… | 1995 |
| * | K933880 | SL Series Surgical Laser SystemsSummary page 1…ser System Dermatology laser system Instrument, surgical, powered, laser 79-GEX 21 CFR 878.48 LaserScope Aura Laser System (K951034) LaserScope SL Series 12 Watt KTP (K933880) The CB Diode/532 consists of the laser enclosure and the fiber optic delivery system. The laser enclosure contains the DC Powe… | 1994 |
What descends from it? (308)
See all 3083 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?
Treatment of cutaneous vascular and pigmented lesions.
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/K954905 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954905: CB Diode/532 Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954905
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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