510(k) · Cleared
ClearedTheraclear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theravant Corporation · GEX Powered Laser Surgical Instrument
Cleared on Jul 8, 2010 as substantially equivalent to K083730 (Aesthera Corporation, 2009) after a 49-day review. Its family tree reaches back 12 generations to 1992. 1 later device descends from it.
- Decided
- Jul 8, 2010
- Review
- 49 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K910422 (1992). 82 ancestors in all, the oldest K892514 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 8 generations between
- 3 generations backK052442 Radiancy Skinstation with Psoriasis Light Unit AssemblyRadiancy (Israel), Ltd. · 2006
- 2 generations backK062048 Aesthera Photopneumatic (PPX) SystemAesthera Corporation · 2006
- 1 generation backK083730 IsolazAesthera Corporation · 2009
- This deviceK101415 TheraclearTheravant Corporation · 2010
- Descendant · cites it directly · 0 of its ownK123889 Acleara, TheraclearTheravant Corporation · 2013
Show all 12 generations
- Root · 12 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 11 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 10 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 9 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 8 generations backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 7 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 6 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 5 generations backK032460 Profile BBL SystemSciton, Inc · 2003
- 4 generations backK050047 Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc. · 2005
- 3 generations backK052442 Radiancy Skinstation with Psoriasis Light Unit AssemblyRadiancy (Israel), Ltd. · 2006
- 2 generations backK062048 Aesthera Photopneumatic (PPX) SystemAesthera Corporation · 2006
- 1 generation backK083730 IsolazAesthera Corporation · 2009
- This deviceK101415 TheraclearTheravant Corporation · 2010
Most influential descendants
Showing 1 of 1 · See all- K123889Acleara, TheraclearTheravant Corporation · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −11 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −10 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −9 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −8 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −7 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −6 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| −5 | K032460 | Profile BBL System | Sciton, Inc | 2003 | — |
| −4 | K050047 | Cutera Optional Pulsed Light Hand Piece Family | Cutera, Inc. | 2005 | — |
| −3 | K052442 | Radiancy Skinstation with Psoriasis Light Unit Assembly | Radiancy (Israel), Ltd. | 2006 | — |
| −2 | K062048 | Aesthera Photopneumatic (PPX) System | Aesthera Corporation | 2006 | — |
| −1 | K083730 | Isolaz | Aesthera Corporation | 2009 | — |
| 0 (this device) | K101415 | Theraclear | Theravant Corporation | 2010 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (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 |
|---|---|---|---|
| * | K083730 | IsolazSummary page 1…r use in general and plastic surgery and in dermatology Ill. Predicate Device(s) * Aesthera Isolaz System (K083730); IV. Product Description The Theravant System is comprised of the following main components: * Mai… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123889 | Acleara, Theraclear | 2013 | 0 |
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 18 years and passes through 10 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 82 ancestors has a recall of any class.
- Of its descendants, K123889 (Theravant Corporation, 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K083730.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Theravant 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, comnedonal 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/K101415 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101415: Theraclear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101415
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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