510(k) · Cleared
ClearedPico Shining (Pico-K; Picofy)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Speclipse, Inc. · GEX Powered Laser Surgical Instrument
Cleared on May 11, 2026 as substantially equivalent to K253342 (Speclipse, Inc., 2025) after a 27-day review. Its family tree reaches back 28 generations to 1995.
- Decided
- May 11, 2026
- Review
- 27 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 28 generations to K943450 (1995). 569 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 backK191685 PicoWay Laser SystemCandela Corporation · 2019
- 2 generations backK202172 StarWalkerFotona D.O.O. · 2020
- 1 generation backK253342 PICO-KSpeclipse, Inc. · 2025
- This deviceK261214 Pico Shining (Pico-K; Picofy)Speclipse, Inc. · 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 backK133364 Picosure WorkstationCynosure, Inc. · 2014
- 9 generations backK140719 Picosure WorkstationCynosure, Inc. · 2014
- 8 generations backK143105 Picosure WorkstationCynosure, Inc. · 2015
- 7 generations backK153527 PicoWay Laser SystemSyneron Candela Corporation · 2016
- 6 generations backK160607 PicoWay Laser SystemSyneron Candela Corporation · 2016
- 5 generations backK162454 PicoWay Laser SystemSyneron Candela Corporation · 2017
- 4 generations backK170597 PicoWay Laser SystemSyneron Candela Corporation · 2017
- 3 generations backK191685 PicoWay Laser SystemCandela Corporation · 2019
- 2 generations backK202172 StarWalkerFotona D.O.O. · 2020
- 1 generation backK253342 PICO-KSpeclipse, Inc. · 2025
- This deviceK261214 Pico Shining (Pico-K; Picofy)Speclipse, Inc. · 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 | K133364 | Picosure Workstation | Cynosure, Inc. | 2014 | — |
| −9 | K140719 | Picosure Workstation | Cynosure, Inc. | 2014 | — |
| −8 | K143105 | Picosure Workstation | Cynosure, Inc. | 2015 | — |
| −7 | K153527 | PicoWay Laser System | Syneron Candela Corporation | 2016 | — |
| −6 | K160607 | PicoWay Laser System | Syneron Candela Corporation | 2016 | — |
| −5 | K162454 | PicoWay Laser System | Syneron Candela Corporation | 2017 | — |
| −4 | K170597 | PicoWay Laser System | Syneron Candela Corporation | 2017 | — |
| −3 | K191685 | PicoWay Laser System | Candela Corporation | 2019 | — |
| −2 | K202172 | StarWalker | Fotona D.O.O. | 2020 | — |
| −1 | K253342 | PICO-K | Speclipse, Inc. | 2025 | — |
| 0 (this device) | K261214 | Pico Shining (Pico-K; Picofy) | Speclipse, Inc. | 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 | 27 | 0 |
| 1995 | 26 | 0 |
| 1996 | 30 | 0 |
| 1997 | 31 | 0 |
| 1998 | 33 | 0 |
| 1999 | 29 | 0 |
| 2000 | 36 | 0 |
| 2001 | 35 | 0 |
| 2002 | 42 | 0 |
| 2003 | 47 | 0 |
| 2004 | 35 | 0 |
| 2005 | 27 | 0 |
| 2006 | 19 | 0 |
| 2007 | 19 | 0 |
| 2008 | 20 | 0 |
| 2009 | 10 | 0 |
| 2010 | 6 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K253342 | PICO-KSummary page 7…fication of Predicate Device(s) [21 CFR 807.92(a)(3)] The identified predicate device within this submission is shown as follow; 510(k) Number K253342 Trade/Device/Model Name PICO-K Common Name Laser Surgical Instrument Device Cl… | 2025 |
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 10 months on median.
- 28 of the 569 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 PICO SHINING is intended for use in the following indications at the specified wavelength:
1064 nm wavelength
-Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple
-Benign pigmented lesions removal for Fitzpatrick Skin Types I-IV
-Treatment of acne scars in Fitzpatrick Skin Types II-V
-Treatment of wrinkles as well as benign pigmented lesions in Fitzpatrick Skin Types I-IV
532 nm wavelength
-Tattoo removal in Skin Types I - III
-Treatment of benign pigmented lesions in Fitzpatrick Skin Types I-IV
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261214: Pico Shining (Pico-K; Picofy).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261214
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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