510(k) · Cleared
ClearedModels Crystal 512, Record 618, Optima 518 Photo Epilation Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Active Optical Systems, Ltd./Efraim Bidas · GEX Powered Laser Surgical Instrument
Cleared on Apr 29, 2005 as substantially equivalent to K030897 (Radiancy (Israel), Ltd., 2003) and 1 other predicate after a 14-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Apr 29, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K030897 (2003). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK030897 SkinstationRadiancy (Israel), Ltd. · 2003
- This deviceK050950 Models Crystal 512, Record 618, Optima 518 Photo Epilation SystemsActive Optical Systems, Ltd./Efraim Bidas · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030897 | Skinstation | Radiancy (Israel), Ltd. | 2003 | — |
| 0 (this device) | K050950 | Models Crystal 512, Record 618, Optima 518 Photo Epilation Systems | Active Optical Systems, Ltd./Efraim Bidas | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 |
|---|---|---|---|
| * | K030897 | SkinstationSummary page 1…class: Class II Reason for 510(k) Submission Traditional 510(k) Submission Identification of Legally Marketed Equivalent Devices SkinStation K030897, StarLux K033549 Device Description The Crystal & Record are two models of the same device. The Optima is an additional commerci… | 2003 |
| * | K033549 | Starlux Pulsed Light SystemSummary page 1…Class II Reason for 510(k) Submission Traditional 510(k) Submission Identification of Legally Marketed Equivalent Devices SkinStation K030897, StarLux K033549 Device Description The Crystal & Record are two models of the same device. The Optima is an additional commercial name of the Re… | 2004 |
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?
- None of the 2 ancestors has a recall.
- 9 other devices also cite its predicate K030897.
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 Crystal , Record & Optima are generally intended for dermatological use. The device is specifically indicated for removal of hair by using selective light energy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050950 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050950: Models Crystal 512, Record 618, Optima 518 Photo Epilation Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050950
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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