510(k) · Cleared
ClearedAhrs Epilator 629
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Hair Removal System Co. · KCX Epilator, High Frequency, Tweezer-Type
Cleared on Aug 14, 1990 after a 490-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1,501 later devices descend from it.
- Decided
- Aug 14, 1990
- Review
- 490 days
- Class
- Class I
- Product code
- KCX
- Recalls
- None
- Predicates
- 0
1,501 later devices descend from it, 2 citing it directly.
- This deviceK892514 Ahrs Epilator 629American Hair Removal System Co. · 1990
- Descendant · cites it directly · 1,499 of its ownK963249 Epilight Hair Removal SystemEsc Medical Systems, Ltd. · 1997
- Descendant · cites it directly · 1,497 of its ownK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- Descendant · 2 generations on · 1,496 of its ownK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- Descendant · 2 generations on · 1,492 of its ownK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- Descendant · 3 generations on · 1,129 of its ownK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
Showing 5 of 1,501 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,501 · See all- K963249Epilight Hair Removal SystemEsc Medical Systems, Ltd. · 1997 · cites it directly1,499descendants
- K962446Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997 · cites it directly1,497descendants
- K974536Photoderm HR SystemEsc Medical Systems, Ltd. · 1998 · 2 generations on1,496descendants
- K991935Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000 · 2 generations on1,492descendants
- K013366Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002 · 3 generations on1,129descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K892514 | Ahrs Epilator 629 | American Hair Removal System Co. | 1990 | — |
| +1 | K963249 | Epilight Hair Removal System | Esc Medical Systems, Ltd. | 1997 | — |
| +1 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| +2 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| +2 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| +3 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 11 | 0 |
| 2003 | 24 | 0 |
| 2004 | 14 | 0 |
| 2005 | 26 | 0 |
| 2006 | 27 | 0 |
| 2007 | 32 | 0 |
| 2008 | 49 | 0 |
| 2009 | 37 | 0 |
| 2010 | 38 | 0 |
| 2011 | 37 | 0 |
| 2012 | 35 | 0 |
| 2013 | 55 | 0 |
| 2014 | 61 | 0 |
| 2015 | 52 | 0 |
| 2016 | 70 | 0 |
| 2017 | 69 | 0 |
| 2018 | 63 | 0 |
| 2019 | 55 | 0 |
| 2020 | 62 | 0 |
| 2021 | 79 | 0 |
| 2022 | 114 | 0 |
| 2023 | 107 | 0 |
| 2024 | 123 | 0 |
| 2025 | 162 | 0 |
| 2026 | 94 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KCX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (1,501)
See all 1,5012 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?
- Of its descendants, K963249 (Esc Medical Systems, Ltd., 1997) has gone furthest, with 1,499 descendants of its own.
How does its category compare?
All KCX devicesKCX Epilator, High Frequency, Tweezer-Type: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KCX
FDA has decided no KCX device since 2007.
Median 510(k) review, days · KCX
Too few KCX 510(k)s in any year since 2007 to give a median.
Recalls per year · KCX
No recall names KCX since 2007.
Adverse event reports per year · KCX
1in 2014
MAUDE reports naming product code KCX, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K892514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K892514: Ahrs Epilator 629.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K892514
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026