510(k) · Cleared
ClearedSharplan Epitouch Alexandrite Laser System (5000)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sharplan Lasers, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Dec 4, 1997 as substantially equivalent to K971874 (Sharplan Lasers, Inc., 1997) after a 90-day review. Its family tree reaches back 2 generations to 1996. 222 later devices descend from it.
- Decided
- Dec 4, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K963094 (1996). 222 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK963094 Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc. · 1996
- 1 generation backK971874 Sharplan Epitouch Alexandrite Laser System (5000)Sharplan Lasers, Inc. · 1997
- This deviceK973354 Sharplan Epitouch Alexandrite Laser System (5000)Sharplan Lasers, Inc. · 1997
- Descendant · cites it directly · 118 of its ownK983977 Light Age Epicare Alexandrite LaserLight Age, Inc. · 1999
- Descendant · cites it directly · 114 of its ownK042474 ARIONWavelight Laser Technologie AG · 2004
- Descendant · 2 generations on · 112 of its ownK081352 Profile Multi-Platform SystemSciton, Inc · 2008
- Descendant · 3 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- Descendant · cites it directly · 110 of its ownK984601 Candela Gentlelase II Dermatological LaserCandela Corp. · 1999
Showing 5 of 222 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 222 · See all- K983977Light Age Epicare Alexandrite LaserLight Age, Inc. · 1999 · cites it directly118descendants
- K042474ARIONWavelight Laser Technologie AG · 2004 · cites it directly114descendants
- K081352Profile Multi-Platform SystemSciton, Inc · 2008 · 2 generations on112descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 3 generations on111descendants
- K984601Candela Gentlelase II Dermatological LaserCandela Corp. · 1999 · cites it directly110descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963094 | Cynosure Photogenica LP Dermatological Vascular Lesion Laser | Cynosure, Inc. | 1996 | — |
| −1 | K971874 | Sharplan Epitouch Alexandrite Laser System (5000) | Sharplan Lasers, Inc. | 1997 | — |
| 0 (this device) | K973354 | Sharplan Epitouch Alexandrite Laser System (5000) | Sharplan Lasers, Inc. | 1997 | — |
| +1 | K983977 | Light Age Epicare Alexandrite Laser | Light Age, Inc. | 1999 | — |
| +1 | K042474 | ARION | Wavelight Laser Technologie AG | 2004 | — |
| +2 | K081352 | Profile Multi-Platform System | Sciton, Inc | 2008 | — |
| +3 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| +1 | K984601 | Candela Gentlelase II Dermatological Laser | Candela Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 10 | 0 |
| 2016 | 6 | 0 |
| 2017 | 11 | 0 |
| 2018 | 12 | 0 |
| 2019 | 10 | 0 |
| 2020 | 15 | 0 |
| 2021 | 10 | 0 |
| 2022 | 29 | 0 |
| 2023 | 13 | 0 |
| 2024 | 22 | 0 |
| 2025 | 23 | 0 |
| 2026 | 19 | 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 |
|---|---|---|---|
| * | K971874 | Sharplan Epitouch Alexandrite Laser System (5000)Summary page 1…Laser System 3. Predicate Devices: The Cynosure Alexandrite Laser (cleared by FDA, August, 1997), and the Sharplan Model 5000 Alexandrite Laser System for Dermatology (K971874) 4. Description: The Sharplan Model Alexandrite Laser System is a medical device which capable of emitting an invisible pulsed t… | 1997 |
| * | — | Cynosure Alexandrite Laser for Hair Removal Named without a submission number |
What descends from it? (222)
See all 2227 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983977 | Light Age Epicare Alexandrite Laser | 1999 | 118 |
| K042474 | ARION | 2004 | 114 |
| K984601 | Candela Gentlelase II Dermatological Laser | 1999 | 110 |
| K032991 | Light Age Epicare Alexandrite Laser, Models 501-1H, 501-SP, 501-LP and 501-LPX | 2004 | 61 |
| K090571 | Alma Lasers ALEX755 Module | 2009 | 58 |
| K990119 | Epi-Star Surgical Laser Syster | 2000 | 50 |
| K982316 | Laseaway Alexandrite Laser System | 1998 | 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 1 year and passes through 2 companies; a new generation was cleared every 8 months on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K983977 (Light Age, Inc., 1999) has gone furthest, with 118 descendants of its own.
- 6 other devices also cite its predicate K971874.
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 Sharplan Model 5000 Alexandrite Laser System is intended for use in dermatology for the removal of unwanted dark body hair.
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/K973354 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973354: Sharplan Epitouch Alexandrite Laser System (5000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973354
Report an extraction error
Are you the manufacturer?
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