510(k) · Cleared
ClearedPALLAS Premium
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 Jan 26, 2023 as substantially equivalent to K191501 (Laseroptek Co., Ltd., 2020) and 1 other predicate after a 56-day review. Its family tree reaches back 8 generations to 1989.
- Decided
- Jan 26, 2023
- Review
- 56 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K885026 (1989). 26 ancestors in all, the oldest K885025 (1989). No later device cites it as a predicate yet.
- Root · 8 generations backK885026 Houva II UvbNational Biological Corp. · 1989
- 7 generations backK992914 Excimer Laser Phototherapy System, AL7000Acculase, Inc. · 2000
- 6 generations backK020591 BclearLumenis · 2002
- 5 generations backK022165 Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2Theralight, Inc. · 2002
- 4 generations backK024020 Theralight UV120-2 Uva/Uvb Phototherapy SystemTheralight, Inc. · 2003
- 3 generations backK062963 Pharos Excimer Laser System, Model EX-308Ra Medical Systems,Inc · 2007 · Recalled
- 2 generations backK172639 PALLAS 308/311 Solid-State UV Laser SystemLaseroptek Co., Ltd. · 2017
- 1 generation backK191501 PALLAS 308/311 Solid-State UV Laser SystemLaseroptek Co., Ltd. · 2020
- This deviceK223588 PALLAS PremiumLaseroptek Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K885026 | Houva II Uvb | National Biological Corp. | 1989 | — |
| −7 | K992914 | Excimer Laser Phototherapy System, AL7000 | Acculase, Inc. | 2000 | — |
| −6 | K020591 | Bclear | Lumenis | 2002 | — |
| −5 | K022165 | Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2 | Theralight, Inc. | 2002 | — |
| −4 | K024020 | Theralight UV120-2 Uva/Uvb Phototherapy System | Theralight, Inc. | 2003 | — |
| −3 | K062963 | Pharos Excimer Laser System, Model EX-308 | Ra Medical Systems,Inc | 2007 | 2 |
| −2 | 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 | — |
| 0 (this device) | 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 |
| 2008 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K191501 | PALLAS 308/311 Solid-State UV Laser SystemSummary page 4…Predicate Device 1 Proposed Device Similar 510(K) K191501 Not Available Number Manufacturer Laseroptek Co., Ltd. Laseroptek Co. Ltd. Device Name… | 2020 |
| * | K193478 | XTRAC Momentum Excimer Laser SystemSummary page 5…Predicate Device 2 Proposed Device Similar 510(K) K193478 Not Available Number Manufacturer Strata Skin Sciences, Inc. Laseroptek Co. Ltd. Device Name… | 2020 |
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 34 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- 2 of the 26 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. 2023, 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?
PALLAS Premium is Solid-State Ultraviolet laser system for treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223588 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223588: PALLAS Premium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223588
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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