510(k) · Cleared
ClearedPALLAS 308/311 Solid-State UV Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laseroptek Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Nov 3, 2017 as substantially equivalent to K020847 (Photo Medex, Inc., 2002) and 1 other predicate after a 63-day review. Its family tree reaches back 6 generations to 1989. 2 later devices descend from it.
- Decided
- Nov 3, 2017
- Review
- 63 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K885026 (1989). 22 ancestors in all, the oldest K885025 (1989). 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK885026 Houva II UvbNational Biological Corp. · 1989
- 5 generations backK992914 Excimer Laser Phototherapy System, AL7000Acculase, Inc. · 2000
- 4 generations backK020591 BclearLumenis · 2002
- 3 generations backK022165 Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2Theralight, Inc. · 2002
- 2 generations backK024020 Theralight UV120-2 Uva/Uvb Phototherapy SystemTheralight, Inc. · 2003
- 1 generation backK062963 Pharos Excimer Laser System, Model EX-308Ra Medical Systems,Inc · 2007 · Recalled
- This deviceK172639 PALLAS 308/311 Solid-State UV Laser SystemLaseroptek Co., Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK191501 PALLAS 308/311 Solid-State UV Laser SystemLaseroptek Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK223588 PALLAS PremiumLaseroptek Co., Ltd. · 2023
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 |
|---|---|---|---|---|---|
| −6 | K885026 | Houva II Uvb | National Biological Corp. | 1989 | — |
| −5 | K992914 | Excimer Laser Phototherapy System, AL7000 | Acculase, Inc. | 2000 | — |
| −4 | K020591 | Bclear | Lumenis | 2002 | — |
| −3 | K022165 | Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2 | Theralight, Inc. | 2002 | — |
| −2 | K024020 | Theralight UV120-2 Uva/Uvb Phototherapy System | Theralight, Inc. | 2003 | — |
| −1 | K062963 | Pharos Excimer Laser System, Model EX-308 | Ra Medical Systems,Inc | 2007 | 2 |
| 0 (this device) | K172639 | PALLAS 308/311 Solid-State UV Laser System | Laseroptek Co., Ltd. | 2017 | — |
| +1 | K191501 | PALLAS 308/311 Solid-State UV Laser System | Laseroptek Co., Ltd. | 2020 | — |
| +2 | K223588 | PALLAS Premium | Laseroptek Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1993 | 3 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K020847 | Xtrac Excimer Laser System, Model AL7000Summary page 4…quivalent to the following legally marketed predicate devices Predicate Device Predicate Device Proposed Device 510(K) Number K020847 K062963 Not Available Manufacturer PhotoMedex, Inc. RA Medical Systems, Inc.… | 2002 |
| * | K062963 | Pharos Excimer Laser System, Model EX-308Summary page 4…g legally marketed predicate devices Predicate Device Predicate Device Proposed Device 510(K) Number K020847 K062963 Not Available Manufacturer PhotoMedex, Inc. RA Medical Systems, Inc. Laseroptek Co. Ltd. Dev… | 2007 |
| † | K024020 | Theralight UV120-2 Uva/Uvb Phototherapy System | 2003 |
| † | K152856 | Helios III | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191501 | PALLAS 308/311 Solid-State UV Laser System | 2020 | 1 |
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 28 years and passes through 6 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 22 ancestors have a recall of any class.
- Of its descendants, K191501 (Laseroptek Co., Ltd., 2020) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K020847.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 indications for use are UVB phototherapy of psoriasis, vitiligo, atopic dermatitis, and leukoderma of affected skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172639 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172639: PALLAS 308/311 Solid-State UV Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172639
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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