510(k) · Cleared
ClearedCuRAS Nd:YAG Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ilooda Co,., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Dec 1, 2017 as substantially equivalent to K122922 (Eclipse Aesthetics, LLC, 2013) after a 64-day review. Its family tree reaches back 14 generations to 1992. 6 later devices descend from it.
- Decided
- Dec 1, 2017
- Review
- 64 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K910422 (1992). 130 ancestors in all, the oldest K820106 (1982). 6 later devices descend from it, 4 citing it directly.
- Root · 14 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 10 generations between
- 3 generations backK103455 Spectra Laser SystemLutronic Corporation · 2011
- 2 generations backK113588 Spectra Laser SystemLutronic Corporation · 2012
- 1 generation backK122922 E-Beam ND: Yag LaserEclipse Aesthetics, LLC · 2013
- This deviceK173038 CuRAS Nd:YAG LaserIlooda Co,., Ltd. · 2017
- Descendant · cites it directly · 2 of its ownK193477 Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK253123 CuRAS hybridClassys, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK252319 Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK231948 MediyagMedicreations, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK232532 Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd. · 2023
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 backK050293 Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP…Fotona D.D. · 2005
- 5 generations backK070355 Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008
- 4 generations backK083889 Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D. · 2009
- 3 generations backK103455 Spectra Laser SystemLutronic Corporation · 2011
- 2 generations backK113588 Spectra Laser SystemLutronic Corporation · 2012
- 1 generation backK122922 E-Beam ND: Yag LaserEclipse Aesthetics, LLC · 2013
- This deviceK173038 CuRAS Nd:YAG LaserIlooda Co,., Ltd. · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd. · 2020 · cites it directly2descendants
- K253123CuRAS hybridClassys, Inc. · 2025 · cites it directly0descendants
- K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd. · 2025 · cites it directly0descendants
- K231948MediyagMedicreations, LLC · 2024 · 2 generations on0descendants
- K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd. · 2023 · 2 generations on0descendants
View 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 | K050293 | Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag… | Fotona D.D. | 2005 | — |
| −5 | K070355 | Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family | Fotona D.D. | 2008 | — |
| −4 | K083889 | Fotona QX ND:Yag/KTP Laser System Family | Fotona D.D. | 2009 | — |
| −3 | K103455 | Spectra Laser System | Lutronic Corporation | 2011 | — |
| −2 | K113588 | Spectra Laser System | Lutronic Corporation | 2012 | — |
| −1 | K122922 | E-Beam ND: Yag Laser | Eclipse Aesthetics, LLC | 2013 | — |
| 0 (this device) | K173038 | CuRAS Nd:YAG Laser | Ilooda Co,., Ltd. | 2017 | — |
| +1 | K193477 | Nd: YAG Laser Therapy Systems | Beijing Kes Biology Technology Co., Ltd. | 2020 | — |
| +1 | K253123 | CuRAS hybrid | Classys, Inc. | 2025 | — |
| +1 | K252319 | Q-Switched Nd: YAG Laser machine (LFS-C13U) | Sanhe Lefis Electronics Co., Ltd. | 2025 | — |
| +2 | K231948 | Mediyag | Medicreations, LLC | 2024 | — |
| +2 | K232532 | Nd:Yag Laser Therapy Systems | Beijing Unt Technology Co., Ltd. | 2023 | — |
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 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K122922 | E-Beam ND: Yag LaserSummary page 4…Accessories III. Predicate Devices [21 CFR 807.92(a) (3)] K# Predicate Device K122922 E-Beam Nd;YAG Laser system IV. Product Description [21 CFR 807.92(a) (4)] The CuRAS Nd;YAG las… | 2013 |
What descends from it? (6)
4 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 25 years and passes through 9 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 130 ancestors have a recall of any class.
- Of its descendants, K193477 (Beijing Kes Biology Technology Co., Ltd., 2020) has gone furthest, with 2 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. 2017, 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 CuRAS Nd;YAG 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 : - Tattoo removal: light ink (red, tan, purple, orange, skyblue, green) - Removal of Epidermal Pigmented Lesions - Removal of Minor Vascular Lesions including but not limited to telangiectasias - Treatment of Lentigines -…
Read the full statement (134 words)
The CuRAS Nd;YAG 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 :
- Tattoo removal: light ink (red, tan, purple, orange, skyblue, green)
- Removal of Epidermal Pigmented Lesions
- Removal of Minor Vascular Lesions including but not limited to telangiectasias
- Treatment of Lentigines
- Treatment of Cafe-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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K173038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173038: CuRAS Nd:YAG Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173038
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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