510(k) · Cleared
ClearedAcleara, Theraclear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theravant Corporation · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on Mar 4, 2013 as substantially equivalent to K101415 (Theravant Corporation, 2010) after a 76-day review. Its family tree reaches back 13 generations to 1992.
- Decided
- Mar 4, 2013
- Review
- 76 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K910422 (1992). 83 ancestors in all, the oldest K892514 (1990). No later device cites it as a predicate yet.
- Root · 13 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 9 generations between
- 3 generations backK062048 Aesthera Photopneumatic (PPX) SystemAesthera Corporation · 2006
- 2 generations backK083730 IsolazAesthera Corporation · 2009
- 1 generation backK101415 TheraclearTheravant Corporation · 2010
- This deviceK123889 Acleara, TheraclearTheravant Corporation · 2013
Show all 13 generations
- Root · 13 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 12 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 11 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 10 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 9 generations backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 8 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 7 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 6 generations backK032460 Profile BBL SystemSciton, Inc · 2003
- 5 generations backK050047 Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc. · 2005
- 4 generations backK052442 Radiancy Skinstation with Psoriasis Light Unit AssemblyRadiancy (Israel), Ltd. · 2006
- 3 generations backK062048 Aesthera Photopneumatic (PPX) SystemAesthera Corporation · 2006
- 2 generations backK083730 IsolazAesthera Corporation · 2009
- 1 generation backK101415 TheraclearTheravant Corporation · 2010
- This deviceK123889 Acleara, TheraclearTheravant Corporation · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −12 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −11 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −10 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −9 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −8 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −7 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| −6 | K032460 | Profile BBL System | Sciton, Inc | 2003 | — |
| −5 | K050047 | Cutera Optional Pulsed Light Hand Piece Family | Cutera, Inc. | 2005 | — |
| −4 | K052442 | Radiancy Skinstation with Psoriasis Light Unit Assembly | Radiancy (Israel), Ltd. | 2006 | — |
| −3 | K062048 | Aesthera Photopneumatic (PPX) System | Aesthera Corporation | 2006 | — |
| −2 | K083730 | Isolaz | Aesthera Corporation | 2009 | — |
| −1 | K101415 | Theraclear | Theravant Corporation | 2010 | — |
| 0 (this device) | K123889 | Acleara, Theraclear | Theravant Corporation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 6 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 5 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 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 ONF? 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 ONF device
- #1 K233473 Deka Lotusscore 18.1 · 27 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K101415 | TheraclearSummary page 1…fication Name: Laser Powered Surgical Instruments K Number: K123889 111. Predicate Device(s) * TheraClear System (K101415); IV. Product Description The Theravant System is comprised of the following main components: *… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 10 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 83 ancestors has a recall of any class.
How does its category compare?
All ONF devicesONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · ONF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONF
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONF
No recall names ONF since 2007.
Adverse event reports per year · ONF
5in 2025
MAUDE reports naming product code ONF, 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 | 1 | — | 0 | 0 |
| 2009 | 5 | 160 | 0 | 0 |
| 2010 | 4 | 137 | 0 | 0 |
| 2011 | 5 | 166 | 0 | 0 |
| 2012 | 3 | 134 | 0 | 0 |
| 2013 | 10 | 113 | 0 | 0 |
| 2014 | 7 | 118 | 0 | 2 |
| 2015 | 3 | 111 | 0 | 4 |
| 2016 | 5 | 87 | 0 | 6 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 4 | 104 | 0 | 1 |
| 2021 | 4 | 101 | 0 | 2 |
| 2022 | 4 | 165 | 0 | 2 |
| 2023 | 5 | 86 | 0 | 2 |
| 2024 | 5 | 168 | 0 | 3 |
| 2025 | 4 | 192 | 0 | 5 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Theravant Acleara/TheraClear System is intended for the treatment of benign vascular and pigmented lesions; permanent hair reduction; and the treatment of mild to moderate acne, including pustular acne, comedonal acne, and mild to moderate inflammatory acne (acne vulgaris), in all skin types (Fitzpatrick I-VI).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123889 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123889: Acleara, Theraclear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123889
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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