510(k) · Cleared
ClearedPicoreMax (PicoreMax)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BLUECORE COMPANY Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Sep 24, 2026 as substantially equivalent to K240983 (Quanta System Spa, 2025) and 2 other predicates after a 269-day review. Its family tree reaches back 27 generations to 1995.
- Decided
- Sep 24, 2026
- Review
- 269 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 27 generations to K943450 (1995). 308 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 27 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 23 generations between
- 3 generations backK172376 Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017
- 2 generations backK191842 Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa · 2019
- 1 generation backK240983 Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa · 2025
- This deviceK254199 PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd. · 2026
Show all 27 generations
- Root · 27 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 26 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 25 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 24 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 23 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 22 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 21 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 20 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 19 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 18 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 17 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 16 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 15 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 14 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 13 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 12 generations backK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- 11 generations backK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
- 10 generations backK121346 Picosure WorkstationCynosure, Inc. · 2012
- 9 generations backK142372 Pico Way Laser SystemCandela Corpation · 2014
- 8 generations backK150326 PicoWay Laser SystemCandela Corporation · 2015
- 7 generations backK152012 EVO platformQuanta System Spa · 2015
- 6 generations backK160368 EVO platformQuanta System Spa · 2016
- 5 generations backK163222 Discovery Pico FamilyQuanta System Spa · 2016
- 4 generations backK171945 Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017
- 3 generations backK172376 Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017
- 2 generations backK191842 Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa · 2019
- 1 generation backK240983 Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa · 2025
- This deviceK254199 PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −27 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −26 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −25 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −24 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −23 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −22 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −21 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −20 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −19 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −18 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −17 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −16 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −15 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −14 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −13 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −12 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| −11 | K103118 | Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor | Hoya Photonics, Inc. | 2010 | 1 |
| −10 | K121346 | Picosure Workstation | Cynosure, Inc. | 2012 | — |
| −9 | K142372 | Pico Way Laser System | Candela Corpation | 2014 | — |
| −8 | K150326 | PicoWay Laser System | Candela Corporation | 2015 | — |
| −7 | K152012 | EVO platform | Quanta System Spa | 2015 | — |
| −6 | K160368 | EVO platform | Quanta System Spa | 2016 | — |
| −5 | K163222 | Discovery Pico Family | Quanta System Spa | 2016 | — |
| −4 | K171945 | Discovery Pico, Discovery Pico Plus | Quanta System Spa | 2017 | — |
| −3 | K172376 | Discovery Pico, Discovery Pico Plus | Quanta System Spa | 2017 | — |
| −2 | K191842 | Discovery Pico, Discovery Pico Plus, Discovery Pico Derm | Quanta System Spa | 2019 | — |
| −1 | K240983 | Discovery Pico; Discovery Pico Plus; Discovery Pico Derm | Quanta System Spa | 2025 | — |
| 0 (this device) | K254199 | PicoreMax (PicoreMax) | BLUECORE COMPANY Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 12 | 0 |
| 1995 | 12 | 0 |
| 1996 | 17 | 0 |
| 1997 | 24 | 0 |
| 1998 | 15 | 0 |
| 1999 | 11 | 0 |
| 2000 | 26 | 0 |
| 2001 | 26 | 0 |
| 2002 | 35 | 0 |
| 2003 | 24 | 0 |
| 2004 | 17 | 0 |
| 2005 | 10 | 0 |
| 2006 | 7 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 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 |
|---|---|---|---|
| * | K240983 | Discovery Pico; Discovery Pico Plus; Discovery Pico DermSummary page 5…878.4810 Product Code GEX III. Predicate and Reference Devices [21 CFR 807.92(a) (3)] Predicate #1 K240983 Predicate Trade Name Discovery Pico; Discovery Pico Plus; Discovery Pico Derm Product Code… | 2025 |
| * | K160488 | Cutera enlighten III Laser SystemSummary page 5…icate Trade Name Discovery Pico; Discovery Pico Plus; Discovery Pico Derm Product Code GEX Predicate #2 K160488 Predicate Trade Name enlighten III Laser System Product Code GEX… | 2016 |
| * | K133254 | Revlite Q-Switched ND:Yag Laser SystemSummary page 5…K160488 Predicate Trade Name enlighten III Laser System Product Code GEX Predicate #3 K133254 Predicate Trade Name RevLite Q-Switched Nd:YAG Laser System Product Code GEX… | 2014 |
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 13 companies; a new generation was cleared every 9 months on median.
- 15 of the 308 ancestors have a recall of any class.
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 PicoreMax is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology and general plastic surgery as follows. 532 nm Indicated for the removal of tattoos for Fitzpatrick skin types I – III to treat the following tattoo colors : red, yellow and orange. Indicated for benign pigmented lesions removal for…
Read the full statement (253 words)
The PicoreMax is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology and general plastic surgery as follows.
532 nm
Indicated for the removal of tattoos for Fitzpatrick skin types I – III to treat the following tattoo colors : red, yellow and orange.
Indicated for benign pigmented lesions removal for Fitzpatrick skin types I – IV.
(nominal delivered energy of 585 nm and 650 nm with the Optional Dye Laser Handpiece)
Tattoo removal (light ink: red, sky blue, green)
Vascular lesions including but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi
Epidermal Pigmented lesions; including, but not limited to: cafe-au-lait birthmarks, solar lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus, seborrheic keratosis
Skin Resurfacing for Acne Scars and Wrinkles
Benign cutaneous lesions; including, but not limited to: striae and scars, (excludes the 650nm wavelength)
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar (excludes the 650nm wavelength)
1064 nm
Indicated for the removal of tattoos for all skin types (Fitzpatrick skin types I – VI) to treat the following tattoo colors : black, brown, green, blue and purple.
Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.
Focus (Fractional) handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I – IV.
Focus (Fractional) handpiece, indicated for the treatment of acne scars in Fitzpatrick Skin Types II – V.
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/K254199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254199: PicoreMax (PicoreMax).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254199
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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