510(k) · Cleared
ClearedQ-Switched Nd: YAG Laser Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Apolo Medical Technology Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on May 4, 2026 as substantially equivalent to K202288 (SNJ Co., Ltd., 2021) and 2 other predicates after a 96-day review. Its family tree reaches back 28 generations to 1995.
- Decided
- May 4, 2026
- Review
- 96 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 28 generations to K943450 (1995). 583 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 28 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 24 generations between
- 3 generations backK191842 Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa · 2019
- 2 generations backK202503 ChromeQuanta System Spa · 2020
- 1 generation backK213569 HOLLYWOOD SPECTRA Laser SystemLutronic Corporation · 2022
- This deviceK260256 Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd. · 2026
Show all 28 generations
- Root · 28 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 27 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 26 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 25 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 24 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 23 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 22 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 21 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 20 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 19 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 18 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 17 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 16 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 15 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 14 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 13 generations backK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- 12 generations backK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
- 11 generations backK121346 Picosure WorkstationCynosure, Inc. · 2012
- 10 generations backK142372 Pico Way Laser SystemCandela Corpation · 2014
- 9 generations backK150326 PicoWay Laser SystemCandela Corporation · 2015
- 8 generations backK152012 EVO platformQuanta System Spa · 2015
- 7 generations backK160368 EVO platformQuanta System Spa · 2016
- 6 generations backK163222 Discovery Pico FamilyQuanta System Spa · 2016
- 5 generations backK171945 Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017
- 4 generations backK172376 Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017
- 3 generations backK191842 Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa · 2019
- 2 generations backK202503 ChromeQuanta System Spa · 2020
- 1 generation backK213569 HOLLYWOOD SPECTRA Laser SystemLutronic Corporation · 2022
- This deviceK260256 Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −28 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −27 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −26 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −25 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −24 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −23 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −22 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −21 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −20 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −19 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −18 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −17 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −16 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −15 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −14 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −13 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| −12 | K103118 | Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor | Hoya Photonics, Inc. | 2010 | 1 |
| −11 | K121346 | Picosure Workstation | Cynosure, Inc. | 2012 | — |
| −10 | K142372 | Pico Way Laser System | Candela Corpation | 2014 | — |
| −9 | K150326 | PicoWay Laser System | Candela Corporation | 2015 | — |
| −8 | K152012 | EVO platform | Quanta System Spa | 2015 | — |
| −7 | K160368 | EVO platform | Quanta System Spa | 2016 | — |
| −6 | K163222 | Discovery Pico Family | Quanta System Spa | 2016 | — |
| −5 | K171945 | Discovery Pico, Discovery Pico Plus | Quanta System Spa | 2017 | — |
| −4 | K172376 | Discovery Pico, Discovery Pico Plus | Quanta System Spa | 2017 | — |
| −3 | K191842 | Discovery Pico, Discovery Pico Plus, Discovery Pico Derm | Quanta System Spa | 2019 | — |
| −2 | K202503 | Chrome | Quanta System Spa | 2020 | — |
| −1 | K213569 | HOLLYWOOD SPECTRA Laser System | Lutronic Corporation | 2022 | — |
| 0 (this device) | K260256 | Q-Switched Nd: YAG Laser Systems | Shanghai Apolo Medical Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 4 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 9 | 0 |
| 1992 | 6 | 0 |
| 1993 | 12 | 0 |
| 1994 | 28 | 0 |
| 1995 | 26 | 0 |
| 1996 | 30 | 0 |
| 1997 | 32 | 0 |
| 1998 | 33 | 0 |
| 1999 | 30 | 0 |
| 2000 | 36 | 0 |
| 2001 | 35 | 0 |
| 2002 | 44 | 0 |
| 2003 | 48 | 0 |
| 2004 | 35 | 0 |
| 2005 | 27 | 0 |
| 2006 | 20 | 0 |
| 2007 | 19 | 0 |
| 2008 | 21 | 0 |
| 2009 | 11 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K202288 | FinebeamSummary page 6…ch Nd: YAG and frequency-double Nd:YAG laser IDevice Description Summary 21 CFR 807.92(a)(4) K202288 I Finebeam IGEX I K213569… | 2021 |
| * | K213569 | HOLLYWOOD SPECTRA Laser SystemSummary page 6…21 CFR 807.92(a)(4) K202288 I Finebeam IGEX I K213569 HOLLYWOOD SPECTRA Laser System IGEX I K190936… | 2022 |
| * | K190936 | Q-Switched Nd: YAG Laser SystemSummary page 6…IGEX I K213569 HOLLYWOOD SPECTRA Laser System IGEX I K190936 Q-Switched Nd: YAG Laser System IGEX Predicate… | 2019 |
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?
- The line of descent spans 31 years and passes through 14 companies; a new generation was cleared every 10 months on median.
- 30 of the 583 ancestors have a recall of any class.
- 1 other device also cites its predicate K202288.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 intended for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology as follows: 532nm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 585nm and 650nm with optional dye handpieces): -Removal of light ink (red, sky blue, green, purple, and orange) tattoo…
Read the full statement (265 words)
The Q-Switched Nd: YAG Laser System is intended for use in tattoo removal, treatment of benign vascular lesions,
treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology as
follows:
532nm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 585nm and 650nm with
optional dye handpieces):
-Removal of light ink (red, sky blue, green, purple, and orange) tattoo,
-Treatment of benign vascular lesions including, but not limited to: telangiectasias,
-Treatment of benign epidermal pigmented lesions including, but not limited to: cafe-au-lait, solar lentiginos, senile
lentiginos, Becher's, nevi Freckles, Nevus spilus, Seborrheic Keratoses,
-Treatment of Post Inflammatory Hyper-Pigmentation,
- Skin resurfacing procedures for the treatment of acne scars and wrinkles.
1064nm in nanosecond mode (with QS, Q-PTP, Q-3, Q-4 function), including microbeam handpieces:
-Removal dark ink (black, blue and brown) tattoo,
-Removal of benign dermal pigmented lesions including, but not limited to: Nevus of OTA, Common Nevi, and Melasma,
-Removal or lightening of unwanted hair with or without adjuvant preparation,
-Skin resurfacing procedures for the treatment of acne scars and wrinkles.
1064nm in SPT mode:
-Treatment of wrinkles,
-Treatment of mild to moderate inflammatory acne vulgaris.
1064nm in LPS (Long pulse) mode:
-Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of PFB. The lasers are
indicated on all skin types Fitzpatrick I-VI including tanned skin,
-Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains,
hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins,
-Coagulation and hemostasis of soft tissue,
-Treatment of wrinkles and acne vulgaris.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260256: Q-Switched Nd: YAG Laser Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260256
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026