510(k) · Cleared
ClearedApex 800 Laser System, 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 May 20, 2002 as substantially equivalent to K992298 (Iridex Corp, 1999) and 4 other predicates after a 66-day review. Its family tree reaches back 4 generations to 1995. 174 later devices descend from it.
- Decided
- May 20, 2002
- Review
- 66 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K950019 (1995). 10 ancestors in all. 174 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 3 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 2 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 1 generation backK992298 Iriderm, Model Apex 800Iridex Corp · 1999
- This deviceK020849 Apex 800 Laser System, Model Apex 800Iridex Corp · 2002
- Descendant · cites it directly · 173 of its ownK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- Descendant · cites it directly · 172 of its ownK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- Descendant · 2 generations on · 171 of its ownK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- Descendant · cites it directly · 169 of its ownK053527 Spectra Hair Removal LaserSpectragenics, Inc. · 2008
- Descendant · 3 generations on · 169 of its ownK072906 SILK'NHome Skinovations, Ltd. · 2008
Showing 5 of 174 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 174 · See all- K032846Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003 · cites it directly173descendants
- K052848Spectra Hair Removal LaserSpectragenics, Inc. · 2005 · cites it directly172descendants
- K060839Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006 · 2 generations on171descendants
- K053527Spectra Hair Removal LaserSpectragenics, Inc. · 2008 · cites it directly169descendants
- K072906SILK'NHome Skinovations, Ltd. · 2008 · 3 generations on169descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −3 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −2 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −1 | K992298 | Iriderm, Model Apex 800 | Iridex Corp | 1999 | — |
| 0 (this device) | K020849 | Apex 800 Laser System, Model Apex 800 | Iridex Corp | 2002 | — |
| +1 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| +1 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| +2 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| +1 | K053527 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2008 | — |
| +3 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K992298 | Iriderm, Model Apex 800Summary page 1…substantially equivalent in intended use and technological characteristics to other currently legally marketed dermatology laser devices including the IRIDERM Apex 800 (K992298), the Coherent LightSheer (K003614), the Cynosure Apogee — TKS and Photogenica DL Laser Systems (K992757 and K010005) and the Pal… | 1999 |
| * | K003614 | Lightsheer Pulsed Diode Array Laser SystemSummary page 1…ed use and technological characteristics to other currently legally marketed dermatology laser devices including the IRIDERM Apex 800 (K992298), the Coherent LightSheer (K003614), the Cynosure Apogee — TKS and Photogenica DL Laser Systems (K992757 and K010005) and the Palomar SLP 1000 (K013028). Device De… | 2001 |
| * | K992757 | Cynosure Apogee-TKS Dermatological LaserSummary page 1…rketed dermatology laser devices including the IRIDERM Apex 800 (K992298), the Coherent LightSheer (K003614), the Cynosure Apogee — TKS and Photogenica DL Laser Systems (K992757 and K010005) and the Palomar SLP 1000 (K013028). Device Description The Apex 800 is a semiconductor diode laser system that del… | 2000 |
| * | K010005 | Cynosure Photogenica DLSummary page 1…tology laser devices including the IRIDERM Apex 800 (K992298), the Coherent LightSheer (K003614), the Cynosure Apogee — TKS and Photogenica DL Laser Systems (K992757 and K010005) and the Palomar SLP 1000 (K013028). Device Description The Apex 800 is a semiconductor diode laser system that delivers pulsed… | 2001 |
| * | K013028 | Palomar SLP 1000Summary page 1…IRIDERM Apex 800 (K992298), the Coherent LightSheer (K003614), the Cynosure Apogee — TKS and Photogenica DL Laser Systems (K992757 and K010005) and the Palomar SLP 1000 (K013028). Device Description The Apex 800 is a semiconductor diode laser system that delivers pulsed infrared 800 nm laser light. Inte… | 2001 |
What descends from it? (174)
See all 1743 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K032846 (Spectragenics, Inc., 2003) has gone furthest, with 173 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 IRIDEX® Apex 800 Laser System is indicated for hair removal and permanent hair reduction on all skin types (Fitzpatrick skin types I-VI), including tanned skin; for the treatment of pseudofolliculitis barbae; for the treatment of vascular lesions including angiomas, hemangiomas, telangiectasia; for the treatment of leg veins; and for the treatment of benign pigmented lesions.
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/K020849 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020849: Apex 800 Laser System, Model Apex 800.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020849
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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