510(k) · Cleared
ClearedSurgilight, Inc Excimer Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgilight, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jul 18, 2000 as substantially equivalent to K935525 (Avex Industries, Ltd., 1995) and 1 other predicate after a 288-day review. Its family tree reaches back 1 generation to 1989. 4 later devices descend from it.
- Decided
- Jul 18, 2000
- Review
- 288 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K885029 (1989). 2 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK885029 Houva II Uva/UvbNational Biological Corp. · 1989
- This deviceK993328 Surgilight, Inc Excimer LaserSurgilight, Inc. · 2000
- Descendant · cites it directly · 3 of its ownK062963 Pharos Excimer Laser System, Model EX-308Ra Medical Systems,Inc · 2007 · Recalled
- Descendant · 2 generations on · 2 of its ownK172639 PALLAS 308/311 Solid-State UV Laser SystemLaseroptek Co., Ltd. · 2017
- Descendant · 3 generations on · 1 of its ownK191501 PALLAS 308/311 Solid-State UV Laser SystemLaseroptek Co., Ltd. · 2020
- Descendant · 4 generations on · 0 of its ownK223588 PALLAS PremiumLaseroptek Co., Ltd. · 2023
Most influential descendants
Showing 4 of 4 · See all- K062963Pharos Excimer Laser System, Model EX-308Ra Medical Systems,Inc · 2007 · cites it directly3descendants
- K172639PALLAS 308/311 Solid-State UV Laser SystemLaseroptek Co., Ltd. · 2017 · 2 generations on2descendants
- K191501PALLAS 308/311 Solid-State UV Laser SystemLaseroptek Co., Ltd. · 2020 · 3 generations on1descendant
- K223588PALLAS PremiumLaseroptek Co., Ltd. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K885029 | Houva II Uva/Uvb | National Biological Corp. | 1989 | — |
| 0 (this device) | K993328 | Surgilight, Inc Excimer Laser | Surgilight, Inc. | 2000 | — |
| +1 | 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 | — |
| +3 | K191501 | PALLAS 308/311 Solid-State UV Laser System | Laseroptek Co., Ltd. | 2020 | — |
| +4 | K223588 | PALLAS Premium | Laseroptek Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2017 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K935525 | Phototherapeutix Model 2480ABSummary page 1…12001 Science Drive Orlando, Florida 32826 J. T Lin, Ph.D. IL Model: SurgiLight, Inc. EX-308 Excimer Laser ITl. Predicate . Devices: The Phototherapeutix, Inc. 2480AB (K935525) and the Natlonal Biological Corporation Houva 11 (K885029). IV. Description: The Surgilight EX-308 Excimer Laser is a medical d… | 1995 |
| * | K885029 | Houva II Uva/UvbSummary page 1…IL Model: SurgiLight, Inc. EX-308 Excimer Laser ITl. Predicate . Devices: The Phototherapeutix, Inc. 2480AB (K935525) and the Natlonal Biological Corporation Houva 11 (K885029). IV. Description: The Surgilight EX-308 Excimer Laser is a medical device that 1s capdble of emitting a treatment laser beam at… | 1989 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062963 | Pharos Excimer Laser System, Model EX-308 | 2007 | 3 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K062963 (Ra Medical Systems,Inc, 2007) has gone furthest, with 3 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 SurgiLight, Inc. EX-308 Excimer laser, handpieces and laser related accessories will be
indicated for use for the treatment of psoriasis. These indications have been cleared for
marketing by the Food and Drug Administration for the cited predicated devices. Surgilight,
Inc. seeks no new indications for the EX-308 Excimer Laser.
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/K993328 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993328: Surgilight, Inc Excimer Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993328
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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