510(k) · Cleared
ClearedSpectra Laser System
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 28, 2011 as substantially equivalent to K080248 (Lutronic Corporation, 2008) and 1 other predicate after a 156-day review. Its family tree reaches back 11 generations to 1992. 92 later devices descend from it.
- Decided
- Apr 28, 2011
- Review
- 156 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K910422 (1992). 126 ancestors in all, the oldest K820106 (1982). 92 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 7 generations between
- 3 generations backK050293 Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP…Fotona D.D. · 2005
- 2 generations backK070355 Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008
- 1 generation backK083889 Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D. · 2009
- This deviceK103455 Spectra Laser SystemLutronic Corporation · 2011
- Descendant · cites it directly · 82 of its ownK113588 Spectra Laser SystemLutronic Corporation · 2012
- Descendant · 2 generations on · 57 of its ownK133254 Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc. · 2014
- Descendant · 3 generations on · 49 of its ownK143105 Picosure WorkstationCynosure, Inc. · 2015
- Descendant · 4 generations on · 41 of its ownK153527 PicoWay Laser SystemSyneron Candela Corporation · 2016
- Descendant · 4 generations on · 34 of its ownK160607 PicoWay Laser SystemSyneron Candela Corporation · 2016
Show all 11 generations
- Root · 11 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 10 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 9 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 8 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 7 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 6 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 5 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 4 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 3 generations backK050293 Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP…Fotona D.D. · 2005
- 2 generations backK070355 Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008
- 1 generation backK083889 Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D. · 2009
- This deviceK103455 Spectra Laser SystemLutronic Corporation · 2011
Showing 5 of 92 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 92 · See all- K113588Spectra Laser SystemLutronic Corporation · 2012 · cites it directly82descendants
- K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc. · 2014 · 2 generations on57descendants
- K143105Picosure WorkstationCynosure, Inc. · 2015 · 3 generations on49descendants
- K153527PicoWay Laser SystemSyneron Candela Corporation · 2016 · 4 generations on41descendants
- K160607PicoWay Laser SystemSyneron Candela Corporation · 2016 · 4 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −10 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −9 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −8 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −7 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −6 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −5 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −4 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −3 | K050293 | Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag… | Fotona D.D. | 2005 | — |
| −2 | K070355 | Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family | Fotona D.D. | 2008 | — |
| −1 | K083889 | Fotona QX ND:Yag/KTP Laser System Family | Fotona D.D. | 2009 | — |
| 0 (this device) | K103455 | Spectra Laser System | Lutronic Corporation | 2011 | — |
| +1 | K113588 | Spectra Laser System | Lutronic Corporation | 2012 | — |
| +2 | K133254 | Revlite Q-Switched ND:Yag Laser System | Cynosure, Inc. | 2014 | — |
| +3 | K143105 | Picosure Workstation | Cynosure, Inc. | 2015 | — |
| +4 | K153527 | PicoWay Laser System | Syneron Candela Corporation | 2016 | — |
| +4 | K160607 | PicoWay Laser System | Syneron Candela Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 8 | 0 |
| 1995 | 7 | 0 |
| 1996 | 9 | 0 |
| 1997 | 9 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 13 | 0 |
| 2001 | 11 | 0 |
| 2002 | 16 | 0 |
| 2003 | 7 | 0 |
| 2004 | 6 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 6 | 0 |
| 2017 | 6 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 8 | 0 |
| 2022 | 9 | 0 |
| 2023 | 5 | 0 |
| 2024 | 11 | 0 |
| 2025 | 15 | 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? (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 |
|---|---|---|---|
| * | K080248 | Spectra Vrmiii Q-Switched ND: Yag Laser System and Dye HandpiecesSummary page 1…ral & Plastic Surgery 3. Predicate Devices The SPECTRA Laser System is substantially equivalent to the Lutronic Corporation Spectra VRMIII Laser System (K080248) and the Fotona QX Nd:YAG/KTP Laser System Family (K0838889). 4. Device Description The SPECTRA Laser System prod… | 2008 |
| * | K083889 | Fotona QX ND:Yag/KTP Laser System Family | 2009 |
What descends from it? (92)
See all 922 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?
- The line of descent spans 19 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 126 ancestors have a recall of any class.
- Of its descendants, K113588 (Lutronic Corporation, 2012) has gone furthest, with 82 descendants of its own.
- 1 other device also cites its predicate K080248.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Laser System in 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): -Tattoo removal: light ink (red, tan, purple, orange, sky blue, green) -Removal of Epidermal Pigmented Lesions -Removal of Minor Vascular Lesions including…
Read the full statement (133 words)
The SPECTRA Laser System in 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):
-Tattoo removal: light ink (red, tan, purple, orange, sky blue, green)
-Removal of Epidermal Pigmented Lesions
-Removal of Minor Vascular Lesions including but not limited to telangiectasias
-Treatment of Lentigines
-Treatment of Caf6-Au-Lait
-Treatment of Seborrheic Keratoses
-Treatment of Post Inflammatory Hyper-Pigmentation
-Treatment of Becker's Nevi, Freckles and Nevi Spilus
1064nm Wavelength:
-Tattoo removal: dark ink (black, blue and brown)
-Removal of Nevus of Ota
-Removal or lightening of unwanted hair with or without adjuvant preparation.
-Treatment of Common Nevi
-Skin resurfacing procedures for the treatment of acne scars and wrinkle
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103455 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103455: Spectra 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/K103455
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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