510(k) · Cleared
ClearedSpectra Vrmiii Q-Switched ND: Yag Laser System and Dye Handpieces
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lutronic Corporation · GEX Powered Laser Surgical Instrument
Cleared on Apr 23, 2008 after an 83-day review. The FDA summary names its predicate without a number. 96 later devices descend from it.
- Decided
- Apr 23, 2008
- Review
- 83 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
96 later devices descend from it, 2 citing it directly.
- This deviceK080248 Spectra Vrmiii Q-Switched ND: Yag Laser System and Dye HandpiecesLutronic Corporation · 2008
- Descendant · cites it directly · 92 of its ownK103455 Spectra Laser SystemLutronic Corporation · 2011
- Descendant · 2 generations on · 82 of its ownK113588 Spectra Laser SystemLutronic Corporation · 2012
- Descendant · 3 generations on · 57 of its ownK133254 Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc. · 2014
- Descendant · 4 generations on · 49 of its ownK143105 Picosure WorkstationCynosure, Inc. · 2015
- Descendant · 5 generations on · 41 of its ownK153527 PicoWay Laser SystemSyneron Candela Corporation · 2016
Showing 5 of 96 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 96 · See all- K103455Spectra Laser SystemLutronic Corporation · 2011 · cites it directly92descendants
- K113588Spectra Laser SystemLutronic Corporation · 2012 · 2 generations on82descendants
- K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc. · 2014 · 3 generations on57descendants
- K143105Picosure WorkstationCynosure, Inc. · 2015 · 4 generations on49descendants
- K153527PicoWay Laser SystemSyneron Candela Corporation · 2016 · 5 generations on41descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080248 | Spectra Vrmiii Q-Switched ND: Yag Laser System and Dye Handpieces | Lutronic Corporation | 2008 | — |
| +1 | K103455 | Spectra Laser System | Lutronic Corporation | 2011 | — |
| +2 | K113588 | Spectra Laser System | Lutronic Corporation | 2012 | — |
| +3 | K133254 | Revlite Q-Switched ND:Yag Laser System | Cynosure, Inc. | 2014 | — |
| +4 | K143105 | Picosure Workstation | Cynosure, Inc. | 2015 | — |
| +5 | K153527 | PicoWay Laser System | Syneron Candela Corporation | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 6 | 0 |
| 2017 | 6 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 9 | 0 |
| 2022 | 9 | 0 |
| 2023 | 5 | 0 |
| 2024 | 11 | 0 |
| 2025 | 16 | 0 |
| 2026 | 11 | 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? (3)
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 |
|---|---|---|---|
| * | — | Lutronic Corporation Spectra VRMII Q-Switched Nd:YAG Laser System Named without a submission number | |
| * | — | HOYA ConBio MedLite C6 Laser System Named without a submission number | |
| * | — | RevLite Laser System Named without a submission number |
What descends from it? (96)
See all 962 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, K103455 (Lutronic Corporation, 2011) has gone furthest, with 92 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. 2008, this device’s year, is highlighted.
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?
The Spectra VRMIII Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. 532nm Wavelength (nominal delivered energy of 585 nm and 650 nm with optional dye handpieces): o Tattoo removal: light ink (red, tan, purple, orange, sky blue, green) o Removal of Epidermal Pigmented Lesions o Removal of Minor Vascular Lesions…
Read the full statement (147 words)
The Spectra VRMIII Laser System is indicated for the incision, excision, ablation,
vaporization of soft tissues for general dermatology, dermatologic and general surgical
procedures for coagulation and hemostasis.
532nm Wavelength (nominal delivered energy of 585 nm and 650 nm with
optional dye handpieces):
o Tattoo removal: light ink (red, tan, purple, orange, sky blue, green)
o Removal of Epidermal Pigmented Lesions
o Removal of Minor Vascular Lesions including but not limited to
telangiectasias
o Treatment of Lentigines
o Treatment of Caf6-Au-Lait
o Treatment of Seborrheic Keratoses
o Treatment of Post Inflammatory Hyper-Pigmentation
o Treatment of Becker's Nevi, Freckles and Nevi Spilus
1064nm Wavelength:
o Tattoo removal: dark ink (black, blue and brown)
o Removal of Nevus of Ota
o Removal or lightening of unwanted hair with or without adjuvant
preparation.
o Treatment of Common Nevi
o Skin resurfacing procedures for the treatment of acne scars and wrinkles
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080248 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080248: Spectra Vrmiii Q-Switched ND: Yag Laser System and Dye Handpieces.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080248
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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