510(k) · Cleared
ClearedApex ER. Yag / Ipl System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sandstone Medical Technologies, LLC · GEX Powered Laser Surgical Instrument
Cleared on Apr 8, 2011 as substantially equivalent to K032599 (Medical Laser Technologies, LLC, 2003) and 1 other predicate after a 65-day review. Its family tree reaches back 10 generations to 1992. 2 later devices descend from it.
- Decided
- Apr 8, 2011
- Review
- 65 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K910422 (1992). 111 ancestors in all, the oldest K820106 (1982). 2 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 6 generations between
- 3 generations backK031828 Naturalase LP ND:Yag LaserFocus Medical, LLC · 2003
- 2 generations backK041829 Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC · 2004
- 1 generation backK081219 Apollo Mini Ipl SystemSandstone Medical Technologies, LLC · 2008
- This deviceK110304 Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC · 2011
- Descendant · cites it directly · 1 of its ownK123777 Multilaser SystemUltralight Laser Technologies, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK233143 PiXel8-RevealRohrer Aesthetics · 2024
Show all 10 generations
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 9 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 8 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 7 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 6 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 5 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 4 generations backK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
- 3 generations backK031828 Naturalase LP ND:Yag LaserFocus Medical, LLC · 2003
- 2 generations backK041829 Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC · 2004
- 1 generation backK081219 Apollo Mini Ipl SystemSandstone Medical Technologies, LLC · 2008
- This deviceK110304 Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC · 2011
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 |
|---|---|---|---|---|---|
| −10 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −9 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −8 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −7 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −6 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −5 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −4 | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II… | Altus Medical, Inc. | 2002 | — |
| −3 | K031828 | Naturalase LP ND:Yag Laser | Focus Medical, LLC | 2003 | — |
| −2 | K041829 | Focus Medical Naturalase LP and Naturalight Family of Products | Focus Medical, LLC | 2004 | — |
| −1 | K081219 | Apollo Mini Ipl System | Sandstone Medical Technologies, LLC | 2008 | — |
| 0 (this device) | K110304 | Apex ER. Yag / Ipl System | Sandstone Medical Technologies, LLC | 2011 | — |
| +1 | K123777 | Multilaser System | Ultralight Laser Technologies, LLC | 2013 | — |
| +2 | K233143 | PiXel8-Reveal | Rohrer Aesthetics | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 8 | 0 |
| 1995 | 7 | 0 |
| 1996 | 9 | 0 |
| 1997 | 11 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 11 | 0 |
| 2001 | 10 | 0 |
| 2002 | 15 | 0 |
| 2003 | 5 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K032599 | Medical Laser Technologies, LLC MTL Erbium:Yag Laser SystemSummary page 1…ation Name: Instrument, Surgical, Powered, laser 79-GEX, 21 CFR 878-48 Legally Marketed Predicate MILT Erbium:YAG Laser System (K)032599 Device: Apollo Mini IPL System (K)081219 Description of the Apex The Apex system and controls are conta… | 2003 |
| * | K081219 | Apollo Mini Ipl SystemSummary page 1…79-GEX, 21 CFR 878-48 Legally Marketed Predicate MILT Erbium:YAG Laser System (K)032599 Device: Apollo Mini IPL System (K)081219 Description of the Apex The Apex system and controls are contained in a single Er:YAG I IPL System: console. Elec… | 2008 |
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 |
|---|---|---|---|
| K123777 | Multilaser System | 2013 | 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 19 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 111 ancestors have a recall of any class.
- Of its descendants, K123777 (Ultralight Laser Technologies, LLC, 2013) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K032599.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Er:YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
The IPL Handpiece is indicated for use in skin types I-IV according to the Fitzpatrick Scale for the following indications:
Hair Removal
(650nm filter)
Permanent hair reduction
(650nm filter)
Treatment of vascular lesions
(Sl0nm filter)
Treatment of benign pigmented lesions
(510 nm filter)
Mild to Moderate inflammatory acne
(450nm filter)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110304 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110304: Apex ER. Yag / Ipl System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110304
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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