510(k) · Cleared
ClearedGalaxy CO2 Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Toplaser Technology Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Apr 18, 2014 as substantially equivalent to K091115 (Lutronic Corporation, 2009) and 2 other predicates after a 116-day review. Its family tree reaches back 14 generations to 1992. 2 later devices descend from it.
- Decided
- Apr 18, 2014
- Review
- 116 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K910422 (1992). 157 ancestors in all, the oldest K820106 (1982). 2 later devices descend from it, 1 citing it directly.
- Root · 14 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 10 generations between
- 3 generations backK071051 Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007
- 2 generations backK080915 Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc. · 2008
- 1 generation backK091115 ECO2 Laser SystemLutronic Corporation · 2009
- This deviceK133915 Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK150587 Cortex Laser SystemCynosure, Inc. Dba Ellman · 2015
- Descendant · 2 generations on · 0 of its ownK161356 Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd · 2016
Show all 14 generations
- Root · 14 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 13 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 12 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 11 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 10 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 9 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 8 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 7 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 6 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 5 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 4 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 3 generations backK071051 Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007
- 2 generations backK080915 Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc. · 2008
- 1 generation backK091115 ECO2 Laser SystemLutronic Corporation · 2009
- This deviceK133915 Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −13 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −12 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −11 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −10 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −9 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −8 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −7 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −6 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −5 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −4 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −3 | K071051 | Fraxel Iii SR Laser System and Accessories | Reliant Technologies, Inc. | 2007 | — |
| −2 | K080915 | Fraxel RE:Pair (Fraxel Iii SR) Laser System and Accessories | Reliant Technologies, Inc. | 2008 | — |
| −1 | K091115 | ECO2 Laser System | Lutronic Corporation | 2009 | — |
| 0 (this device) | K133915 | Galaxy CO2 Laser System | Beijing Toplaser Technology Co., Ltd. | 2014 | — |
| +1 | K150587 | Cortex Laser System | Cynosure, Inc. Dba Ellman | 2015 | — |
| +2 | K161356 | Matrix LS-40 CO2 Laser System | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1993 | 5 | 0 |
| 1994 | 13 | 0 |
| 1995 | 10 | 0 |
| 1996 | 13 | 0 |
| 1997 | 10 | 0 |
| 1998 | 9 | 0 |
| 1999 | 7 | 0 |
| 2000 | 12 | 0 |
| 2001 | 10 | 0 |
| 2002 | 15 | 0 |
| 2003 | 13 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 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? (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 |
|---|---|---|---|
| * | K091115 | ECO2 Laser SystemSummary page 1…urgical Instrument Regulation Number: 21 CFR 878.4810 Product Code: ONG, GEX Panel: General and Plastic Surgery Model: C0 2-2B3 4. Predicate Devices: eCO2 Laser System (K091115), Manufactured by Lutronic Corporation. YouLaserCO2 Laser System (K111592) , Manufactured by Quanta System SpA Slim Evolution 11C… | 2009 |
| * | K111592 | Youlaser CO2 Laser SystemSummary page 1…EX Panel: General and Plastic Surgery Model: C0 2-2B3 4. Predicate Devices: eCO2 Laser System (K091115), Manufactured by Lutronic Corporation. YouLaserCO2 Laser System (K111592) , Manufactured by Quanta System SpA Slim Evolution 11C02 Laser and Delivery Device Accessories X110984) Manufactured by Lasering… | 2011 |
| * | K110984 | Slim E30 II CO2 LaserSummary page 2…ially equivalent to the predicate devices, eCO2 laser system (K091115), YouLaser C02 Laser System (K111592) ,Slim Evolution 110C02 Laser and Delivery Device Accessories (K1 10984) 8. Testing Galaxy 002 Laser System (C02-2B) is designed, tested and will be manufactured in accordance with both mandatory and… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150587 | Cortex Laser System | 2015 | 1 |
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 22 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 157 ancestors have a recall of any class.
- Of its descendants, K150587 (Cynosure, Inc. Dba Ellman, 2015) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K091115.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 C02-28 Galaxy C02 Laser System is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, general surgery. Dermatology, Plastic Surgery and General Surgery procedures: Laser skin resurfacing. Treatment of furrows and wrinkles. Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos,telangiectasia, squamous and basal cell…
Read the full statement (92 words)
The C02-28 Galaxy C02 Laser System is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, general surgery.
Dermatology, Plastic Surgery and General Surgery procedures:
Laser skin resurfacing.
Treatment of furrows and wrinkles.
Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos,telangiectasia, squamous and basal cell carcinoma, warts and uneven pigmentation.
Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
Blepharoplasty.
Site preparation for hair transplants.
The fractional scanner is for treatment of wrinkles and skin resurfacing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133915 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133915: Galaxy CO2 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/K133915
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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