510(k) · Cleared
ClearedQ-Switched ND:Yag Laser System, Model Globalcure-SC6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Technology Laser Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jul 29, 2010 as substantially equivalent to K073436 (Lutronic Corporation, 2007) after an 8-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Jul 29, 2010
- Review
- 8 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K073436 (2007). No later device cites it as a predicate yet.
- Root · 1 generation backK073436 Spectra Vrmii 1-Switched ND:Yag Laser SystemLutronic Corporation · 2007
- This deviceK102050 Q-Switched ND:Yag Laser System, Model Globalcure-SC6Advanced Technology Laser Co., Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K073436 | Spectra Vrmii 1-Switched ND:Yag Laser System | Lutronic Corporation | 2007 | — |
| 0 (this device) | K102050 | Q-Switched ND:Yag Laser System, Model Globalcure-SC6 | Advanced Technology Laser Co., Ltd. | 2010 | — |
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 |
|---|---|---|---|
| * | K073436 | Spectra Vrmii 1-Switched ND:Yag Laser SystemSummary page 2…Regulation Number: 21 CFR 878.48 10; Product Code: GEX Panel: 878 General and Plastic Surgery 5. Predicate Device Spectra VRMVII (Q-Switched Nd:YAG) (K073436) 6. IDevice Description The Q-Switched Nd:YAG Laser System is a new device for 510(k) submission and shares the same… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Q-Switched Nd:YAG 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: Removal of light ink (Red, Tan, Purple, and Orange) Tattoos Removal of Epidermal Pigmented Lesions Removal of Minor Vascular Lesions Treatment of Lentigines Treatment of Café-Au-Lait Treatment of Seborrheic Keratoses…
Read the full statement (115 words)
The Q-Switched Nd:YAG 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: Removal of light ink (Red, Tan, Purple, and Orange) Tattoos
Removal of Epidermal Pigmented Lesions
Removal of Minor Vascular Lesions
Treatment of Lentigines
Treatment of Café-Au-Lait
Treatment of Seborrheic Keratoses
Treatment of Post Inflammatory Hyper-Pigmentation
Treatment of Becker's Nevi, Freckles and Nevi Spilus
1064nm Wavelength: Removal of dark ink (Black, Blue and Brown) Tattoos
Removal of Nevus of Ota
Removal of lightening of unwanted hair with or without adjuvant
preparation
Treatment of Common Nevi
Skin resurfacing procedures for the treatment of acne scars and
wrinkles
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102050 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102050: Q-Switched ND:Yag Laser System, Model Globalcure-SC6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102050
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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