510(k) · Cleared
ClearedIriderm, Model Apex 800
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iridex Corp · GEX Powered Laser Surgical Instrument
Cleared on Dec 9, 1999 as substantially equivalent to K971737 (Cynosure, Inc., 1997) and 1 other predicate after a 154-day review. Its family tree reaches back 3 generations to 1995. 175 later devices descend from it.
- Decided
- Dec 9, 1999
- Review
- 154 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K950019 (1995). 5 ancestors in all. 175 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 2 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 1 generation backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- This deviceK992298 Iriderm, Model Apex 800Iridex Corp · 1999
- Descendant · cites it directly · 174 of its ownK020849 Apex 800 Laser System, Model Apex 800Iridex Corp · 2002
- Descendant · 2 generations on · 173 of its ownK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- Descendant · 2 generations on · 172 of its ownK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- Descendant · 3 generations on · 171 of its ownK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- Descendant · 2 generations on · 169 of its ownK053527 Spectra Hair Removal LaserSpectragenics, Inc. · 2008
Showing 5 of 175 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 175 · See all- K020849Apex 800 Laser System, Model Apex 800Iridex Corp · 2002 · cites it directly174descendants
- K032846Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003 · 2 generations on173descendants
- K052848Spectra Hair Removal LaserSpectragenics, Inc. · 2005 · 2 generations on172descendants
- K060839Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006 · 3 generations on171descendants
- K053527Spectra Hair Removal LaserSpectragenics, Inc. · 2008 · 2 generations on169descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −2 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −1 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| 0 (this device) | K992298 | Iriderm, Model Apex 800 | Iridex Corp | 1999 | — |
| +1 | K020849 | Apex 800 Laser System, Model Apex 800 | Iridex Corp | 2002 | — |
| +2 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| +2 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| +3 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| +2 | K053527 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 8 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 9 | 0 |
| 2019 | 6 | 0 |
| 2020 | 2 | 0 |
| 2021 | 15 | 0 |
| 2022 | 24 | 0 |
| 2023 | 30 | 0 |
| 2024 | 22 | 0 |
| 2025 | 18 | 0 |
| 2026 | 10 | 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 |
|---|---|---|---|
| * | K971737 | Cynosure Photogenica Lpir Dermatological LaserSummary page 1…ex 800 Dermatology Laser System is substantially equivalent to other currently legally marketed dermatology laser devices including the Cynosure, Inc., PhotoGenica LPIR (K971737) and the Coherent, Inc., LightSheer (K973324). Device Description The IRIDERM Apex 800 is a semiconductor diode laser system th… | 1997 |
| * | K973324 | Starlight Pulsed Diode Array Laser SystemSummary page 1…lly equivalent to other currently legally marketed dermatology laser devices including the Cynosure, Inc., PhotoGenica LPIR (K971737) and the Coherent, Inc., LightSheer (K973324). Device Description The IRIDERM Apex 800 is a semiconductor diode laser system that delivers pulsed infrared 800 nm laser ligh… | 1997 |
What descends from it? (175)
See all 1751 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020849 | Apex 800 Laser System, Model Apex 800 | 2002 | 174 |
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 4 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K020849 (Iridex Corp, 2002) has gone furthest, with 174 descendants of its own.
- 7 other devices also cite its predicate K971737.
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 IRIDERM Apex 800 is indicated for hair removal.
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/K992298 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992298: Iriderm, Model Apex 800.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992298
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