510(k) · Cleared
ClearedPastelle Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wontech Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Feb 14, 2025 as substantially equivalent to K213569 (Lutronic Corporation, 2022) and 2 other predicates after a 260-day review. Its family tree reaches back 28 generations to 1995. 3 later devices descend from it.
- Decided
- Feb 14, 2025
- Review
- 260 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 28 generations to K943450 (1995). 305 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 3 citing it directly.
- 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 deviceK241527 Pastelle ProWontech Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK253344 Bellus-QSpeclipse, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK251464 TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated · 2025
- Descendant · cites it directly · 0 of its ownK250165 PastelleWontech Co., Ltd. · 2025
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 deviceK241527 Pastelle ProWontech Co., Ltd. · 2025
Most influential descendants
Showing 3 of 3 · See allView 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) | K241527 | Pastelle Pro | Wontech Co., Ltd. | 2025 | — |
| +1 | K253344 | Bellus-Q | Speclipse, Inc. | 2025 | — |
| +1 | K251464 | TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) | Jeisys Medical Incorporated | 2025 | — |
| +1 | K250165 | Pastelle | Wontech Co., Ltd. | 2025 | — |
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 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K213569 | HOLLYWOOD SPECTRA Laser SystemSummary page 6…R 807.92(a)(3)] The identified predicate devices within this submission are shown as follow: Predicate device 1 ⚫ 510(k) Number: K213569 ⚫ Applicant: Lutronic Page 1 / 6 === Pa… | 2022 |
| * | K161670 | Lucid Q-PTP / HWA 55Summary page 7…Code: GEX ⚫ Trade Name: HOLLYWOOD SPECTRA Laser System Predicate device 2 ⚫ 510(k) Number: K161670 ⚫ Applicant: Bison Medical Co., Ltd. ⚫ Classification Name: Laser surgical in… | 2016 |
| * | K202503 | ChromeSummary page 7…⚫ Product Code: GEX ⚫ Trade Name: Lucid Q-PTP Predicate device 3 ⚫ 510(k) Number: K202503 ⚫ Applicant: Quanta System Spa ⚫ Classification Name: Laser surgical instrume… | 2020 |
What descends from it? (3)
3 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 30 years and passes through 14 companies; a new generation was cleared every 10 months on median.
- 15 of the 305 ancestors have a recall of any class.
- Of its descendants, K253344 (Speclipse, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K213569.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Pastelle Pro system is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. 1064nm in nanosecond mode, including microbeam handpieces: - Tattoo removal: dark ink (black, blue, and brown) - Removal of Nevus of Ota - Removal or lightening of unwanted hair with or without…
Read the full statement (197 words)
The Pastelle Pro system is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision,
ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for
coagulation and hemostasis.
1064nm in nanosecond mode, including microbeam handpieces:
- 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 wrinkles
- Treatment of melasma
1064nm in Genesis (long-pulse) mode:
- Treatment of wrinkles
- Treatment of mild to moderate inflammatory acne vulgaris
532nm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 595 nm and 660 nm with
optional dye handpieces):
- Tattoo removal: light ink (red, tan, purple, orange, sky blue, green)
- Removal of Epidermal Pigmented Lesions
- Removal of Minor Vascular Lesions including but not limited to telangiectasias
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Treatment of Lentigines
- Treatment of Café-au-Lait
- Treatment of Seborrheic Keratoses
- Treatment of Post Inflammatory Hyperpigmentation
- Treatment of Becker's Nevi, Freckles, and Nevi spilus
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241527: Pastelle Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241527
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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