510(k) · Cleared
ClearedMedlite/755 Alexandrite 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 Sep 11, 1996 as substantially equivalent to K950684 (Cynosure, Inc., 1995) after a 183-day review. Its family tree reaches back 1 generation to 1995. 3 later devices descend from it.
- Decided
- Sep 11, 1996
- Review
- 183 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950684 (1995). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK950684 Cynosure Photogenica T10 Tattoo Removal LaserCynosure, Inc. · 1995
- This deviceK961006 Medlite/755 Alexandrite Laser SystemContinuum Biomedical, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK982316 Laseaway Alexandrite Laser SystemSilver Creek, Inc. · 1998
- Descendant · 2 generations on · 0 of its ownK990043 Smoothlase Alexandrite Laser SystemLeisegang Medical, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK980131 Alex TA2 EraserLight Age, Inc. · 1998
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950684 | Cynosure Photogenica T10 Tattoo Removal Laser | Cynosure, Inc. | 1995 | — |
| 0 (this device) | K961006 | Medlite/755 Alexandrite Laser System | Continuum Biomedical, Inc. | 1996 | — |
| +1 | K982316 | Laseaway Alexandrite Laser System | Silver Creek, Inc. | 1998 | — |
| +2 | K990043 | Smoothlase Alexandrite Laser System | Leisegang Medical, Inc. | 1999 | — |
| +1 | K980131 | Alex TA2 Eraser | Light Age, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 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 |
|---|---|---|---|
| * | K950684 | Cynosure Photogenica T10 Tattoo Removal LaserSummary page 1…arch 11, 1996 Medlite\755™ Alexandrite Laser System Dermatology laser system Instrument, surgical, powered, laser 79-GEX 21 CFR 878.48 PhotoGenicaT10 Laser (Cynosure) K950684 The Medlite\755 Alexandrite Laser is a flashlamp excited Q-switched solid state laser producing a broadband wavelength of 755 +2… | 1995 |
What descends from it? (3)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K982316 (Silver Creek, Inc., 1998) has gone furthest, with 1 descendant 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?
Treatment of 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/K961006 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961006: Medlite/755 Alexandrite Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961006
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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