510(k) · Cleared
ClearedFinebeam
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SNJ Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Nov 19, 2021 as substantially equivalent to K083889 (Fotona D.D., 2009) and 6 other predicates after a 464-day review. Its family tree reaches back 22 generations to 1995. 2 later devices descend from it.
- Decided
- Nov 19, 2021
- Review
- 464 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 22 generations to K943450 (1995). 549 ancestors in all, the oldest K771218 (1978). 2 later devices descend from it, 2 citing it directly.
- Root · 22 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations between
- 3 generations backK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- 2 generations backK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- 1 generation backK171227 StarWalkerFotona D.O.O. · 2017
- This deviceK202288 FinebeamSNJ Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK260256 Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK243780 HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd. · 2025
Show all 22 generations
- Root · 22 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 21 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 20 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 19 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 18 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 17 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 16 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 15 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 14 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 13 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 12 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 11 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 10 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 9 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 8 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 7 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 6 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- 5 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 4 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- 3 generations backK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- 2 generations backK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- 1 generation backK171227 StarWalkerFotona D.O.O. · 2017
- This deviceK202288 FinebeamSNJ Co., Ltd. · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −21 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −20 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −19 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −18 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −17 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −16 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −15 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −14 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −13 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −12 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −11 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −10 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −9 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −8 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −7 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −6 | K083682 | 180W Cerelas D 980NM Diode Laser, Model D180 | Biolitec, Inc. | 2009 | — |
| −5 | K082230 | Vectra Plus Laser System and Accessories | Xintec Corporation | 2010 | — |
| −4 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| −3 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
| −2 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
| −1 | K171227 | StarWalker | Fotona D.O.O. | 2017 | — |
| 0 (this device) | K202288 | Finebeam | SNJ Co., Ltd. | 2021 | — |
| +1 | K260256 | Q-Switched Nd: YAG Laser Systems | Shanghai Apolo Medical Technology Co., Ltd. | 2026 | — |
| +1 | K243780 | HELIOS 785 Pico (1754V2) | Laseroptek Co., Ltd. | 2025 | — |
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 | 28 | 0 |
| 2000 | 36 | 0 |
| 2001 | 35 | 0 |
| 2002 | 42 | 0 |
| 2003 | 47 | 0 |
| 2004 | 34 | 0 |
| 2005 | 28 | 0 |
| 2006 | 17 | 0 |
| 2007 | 17 | 0 |
| 2008 | 20 | 0 |
| 2009 | 10 | 0 |
| 2010 | 5 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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? (7)
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 |
|---|---|---|---|
| * | K083889 | Fotona QX ND:Yag/KTP Laser System FamilySummary page 5…GEX 4. Primary Predicate Device - Device Name: Fotona QX Nd:YAG/KTP Laser System Family - 510(k) Number: K083889 - Manufacturer: Fotona d.d 5. Additional Predicate Devices Finebeam Dual – 510(k)… | 2009 |
| * | K132286 | Hyperion Long Pulsed ND: Yag LaserSummary page 6…l 19, Guro-gu, Seoul, Republic of Korea - Device Name: Hyperion Long Plused Nd:YAG Laser - 510(k) Number: K132286 - Manufacturer: Laseroptek Co. Ltd. - Device Name: StarWalker Las… | 2014 |
| * | K171227 | StarWalkerSummary page 6…rer: Laseroptek Co. Ltd. - Device Name: StarWalker Laser System Family - 510(k) Number: K171227 - Manufacturer: Fotona d.o.o. - Device Name: Long pulse Nd:YAG L… | 2017 |
| * | K140249 | Long Pulse ND: Yag Laser SystemSummary page 6…facturer: Fotona d.o.o. - Device Name: Long pulse Nd:YAG Laser System - 510(k) Number: K140249 - Manufacturer: Advanced Technology Laser Company, Ltd - Device Name:… | 2014 |
| * | K123293 | Pastelle Q-Switched ND: Yag LaserSummary page 6…ced Technology Laser Company, Ltd - Device Name: Pastelle Q-Switched Nd:YAG Laser System - 510(k) Number: K123293 - Manufacturer: WON Technology Co., Ltd. 6. Device Description The Finebeam Dual is design… | 2013 |
| * | K090126 | Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Summary page 12…Same Regulation Number 21 CFR 878.4810 Same Same K number K090126 K132185 K202288 Applicant Fotona d.o.o.… | 2009 |
| * | K132185 | Family of Coolglide Aesthetic LasersSummary page 12…ulation Number 21 CFR 878.4810 Same Same K number K090126 K132185 K202288 Applicant Fotona d.o.o. Cutera, Inc.… | 2013 |
What descends from it? (2)
2 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 26 years and passes through 10 companies; a new generation was cleared every 11 months on median.
- 26 of the 549 ancestors have a recall of any class.
- Of its descendants, K260256 (Shanghai Apolo Medical Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K083889.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Finebeam Dual is a surgical laser instrument intended to provide laser energy in two different operation modes (Q-switched (QSW) and long pulse (LPS)) with 1064nm or 532 nm wavelength per each function for use in a variety of dermatological procedures. Each function is intended for: 1) QSW mode with 1064nm single or 1064nm photoacoustic double pulse (PDP) function - Removal dark ink (black, blue, and brown) tattoos; - Treatment melasma, treatment…
Read the full statement (342 words)
The Finebeam Dual is a surgical laser instrument intended to provide laser energy in two different operation modes (Q-switched (QSW) and long pulse (LPS)) with 1064nm or 532 nm wavelength per each function for use in a variety of dermatological procedures. Each function is intended for:
1) QSW mode with 1064nm single or 1064nm photoacoustic double pulse (PDP) function
- Removal dark ink (black, blue, and brown) tattoos;
- Treatment melasma, treatment nevus of Ota;
- Treatment common nevi;
- Removal of lightening of unwanted hair; and
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
2) QSW mode with 532nm single function
- Removal of light ink (red, tan, purple, and orange) tattoos;
- Treatment of vascular lesions including, but not limited to port-wine stains, telangiectasias, spider angioma, cherry angioma;
- Treatment of pigmented lesions including, but not limited to cafe-au-Lait birthmarks, solar lentigines, senile lentigines, Becker's nevi, freckles, common nevi, and nevus spilus;
- Treatment of seborrheic keratosis;
- Treatment of post-inflammatory hyperpigmentation; and
- Skin resurfacing procedures for the treatment of acne scars and wrinkles in the QSW mode with 532nm single function;
3) QSW mode with 1064nm Non-Q function
- Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of Pseudofolliculitis Barbae (PFB). The laser is indicated for all skin types, Fitzpatrick [-VI, including tanned skin;
- Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, cherry angioma, Hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins, Coagulation and hemostasis of soft tissue; and
- Treatment of wrinkles
4) LPS 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202288 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202288: Finebeam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202288
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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