510(k) · Cleared
ClearedTristar Aesthetic Workstation 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 Jan 21, 2004 after a 112-day review. The FDA summary names its predicate without a number. 522 later devices descend from it.
- Decided
- Jan 21, 2004
- Review
- 112 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
522 later devices descend from it, 4 citing it directly.
- This deviceK033176 Tristar Aesthetic Workstation LaserCynosure, Inc. · 2004
- Descendant · cites it directly · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- Descendant · cites it directly · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- Descendant · 2 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- Descendant · 3 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
- Descendant · 2 generations on · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
Showing 5 of 522 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 522 · See all- K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · cites it directly517descendants
- K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · cites it directly266descendants
- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 2 generations on221descendants
- K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 3 generations on202descendants
- K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · 2 generations on198descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033176 | Tristar Aesthetic Workstation Laser | Cynosure, Inc. | 2004 | — |
| +1 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
| +1 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| +2 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| +3 | K073063 | 15W Ceralas D 1470NM Diode Laser | Biolitec, Inc. | 2008 | — |
| +2 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 8 | 0 |
| 2008 | 15 | 0 |
| 2009 | 6 | 0 |
| 2010 | 14 | 0 |
| 2011 | 14 | 0 |
| 2012 | 11 | 0 |
| 2013 | 14 | 0 |
| 2014 | 20 | 0 |
| 2015 | 20 | 0 |
| 2016 | 32 | 0 |
| 2017 | 24 | 0 |
| 2018 | 26 | 0 |
| 2019 | 15 | 0 |
| 2020 | 33 | 0 |
| 2021 | 27 | 0 |
| 2022 | 42 | 0 |
| 2023 | 33 | 0 |
| 2024 | 63 | 0 |
| 2025 | 61 | 0 |
| 2026 | 38 | 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 |
|---|---|---|---|
| * | — | VLS-Star Named without a submission number | |
| * | — | PhotoGenica YAG lasers Named without a submission number |
What descends from it? (522)
See all 5224 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, K042000 (Msq (M2), Ltd., 2004) has gone furthest, with 517 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?
585nm - 600nm: The TriStar Aesthetic Workstation laser is indicated for benign vascular and vascular dependent lesions removal. 1064nm: The TriStar laser is intended for the coagulation and hemostasis of benign vascular leasions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus laske, leg veins, spider veins and poikiloderma of civatte and treatment of benign cutaneous lesions such as but not limited to…
Read the full statement (205 words)
585nm - 600nm: The TriStar Aesthetic Workstation laser is indicated for benign vascular and vascular dependent lesions removal.
1064nm: The TriStar laser is intended for the coagulation and hemostasis of benign vascular leasions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus laske, leg veins, spider veins and poikiloderma of civatte and treatment of benign cutaneous lesions such as but not limited to, lentigos (age spots), solar lentigos (sun spots), cafr au lait macules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques.
The laser is also indicated for thiotreatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
Additionally, the laser is indicated for the removal of unwanted hair, for the stable long tern, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment of psuedofolliculitis barbae (PFB).
1320 nm: The TriStar laser is indicated for use in gental surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles. It is also indicated for the treatment of fine lines and wrinkles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033176 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033176: Tristar Aesthetic Workstation Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033176
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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