510(k) · Cleared
ClearedCynosure Photogenica V-Star Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cynosure, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Feb 13, 2006 after a 48-day review. The FDA summary names its predicate without a number. 199 later devices descend from it.
- Decided
- Feb 13, 2006
- Review
- 48 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
199 later devices descend from it, 1 citing it directly.
- This deviceK053608 Cynosure Photogenica V-Star LaserCynosure, Inc. · 2006
- Descendant · cites it directly · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- Descendant · 2 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- Descendant · 2 generations on · 92 of its ownK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 87 of its ownK121346 Picosure WorkstationCynosure, Inc. · 2012
- Descendant · 4 generations on · 70 of its ownK142372 Pico Way Laser SystemCandela Corpation · 2014
Showing 5 of 199 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 199 · See all- K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · cites it directly198descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 2 generations on111descendants
- K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · 2 generations on92descendants
- K121346Picosure WorkstationCynosure, Inc. · 2012 · 3 generations on87descendants
- K142372Pico Way Laser SystemCandela Corpation · 2014 · 4 generations on70descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K053608 | Cynosure Photogenica V-Star Laser | Cynosure, Inc. | 2006 | — |
| +1 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| +2 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| +2 | K103118 | Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor | Hoya Photonics, Inc. | 2010 | 1 |
| +3 | K121346 | Picosure Workstation | Cynosure, Inc. | 2012 | — |
| +4 | K142372 | Pico Way Laser System | Candela Corpation | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 9 | 0 |
| 2015 | 9 | 0 |
| 2016 | 8 | 0 |
| 2017 | 12 | 0 |
| 2018 | 13 | 0 |
| 2019 | 9 | 0 |
| 2020 | 15 | 0 |
| 2021 | 14 | 0 |
| 2022 | 25 | 0 |
| 2023 | 12 | 0 |
| 2024 | 23 | 0 |
| 2025 | 24 | 0 |
| 2026 | 19 | 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 |
|---|---|---|---|
| * | — | Cynosure PhotoGenica VLS-Star Laser Named without a submission number |
What descends from it? (199)
See all 1991 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083899 | Revlite Q-Switched ND:Yag Laser System | 2009 | 198 |
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, K083899 (Hoya Conbio, Inc., 2009) has gone furthest, with 198 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?
General Surgery: Photocoagulation of benign cutaneous vascular and vascular dependent lesions and benign cutaneous lesions.
Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, striae and psoriasis and the treatment of wrinkles. Treatment of Benign Epidermal Pigmented Lesions.
Treatment of Inflammatory Acne Vulgaris
Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology.
Podiatry: Treatment of benign cutaneous lesions, such as warts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053608 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053608: Cynosure Photogenica V-Star Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053608
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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