510(k) · Cleared
ClearedLooper (Model: ZX-579S)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heat IN A Click, LLC · OLP Over-The-Counter Powered Light Based Laser For Acne
Cleared on Apr 16, 2021 as substantially equivalent to K171821 (Heat IN A Click, 2018) and 2 other predicates after a 266-day review. Its family tree reaches back 15 generations to 1995. 3 later devices descend from it.
- Decided
- Apr 16, 2021
- Review
- 266 days
- Class
- Class II
- Product code
- OLP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K943450 (1995). 159 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 3 citing it directly.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK111286 Quasar CalypsoSilver Bay, LLC · 2012
- 2 generations backK162098 LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017
- 1 generation backK171821 2 Face / Face EvolutionHeat IN A Click · 2018
- This deviceK202055 Looper (Model: ZX-579S)Heat IN A Click, LLC · 2021
- Descendant · cites it directly · 0 of its ownK241203 PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA…Dongguan Hunter Electronic Technology Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK232863 Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK220064 Synergy Marble (Model: Opasm)Yrs Group, Inc. · 2022
Show all 15 generations
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 10 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 9 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 8 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 7 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 6 generations backK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
- 5 generations backK060792 IllumimedPhotoactif, LLC · 2006
- 4 generations backK083183 Aklarus Phototherapy SystemHill Laboratories Co. · 2009
- 3 generations backK111286 Quasar CalypsoSilver Bay, LLC · 2012
- 2 generations backK162098 LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017
- 1 generation backK171821 2 Face / Face EvolutionHeat IN A Click · 2018
- This deviceK202055 Looper (Model: ZX-579S)Heat IN A Click, LLC · 2021
Most influential descendants
Showing 3 of 3 · See all- K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT…Dongguan Hunter Electronic Technology Co., Ltd. · 2024 · cites it directly0descendants
- K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2023 · cites it directly0descendants
- K220064Synergy Marble (Model: Opasm)Yrs Group, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −14 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −10 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −9 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −8 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −7 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −6 | K042630 | Revlight Skin Care System | Skincare Technology, Inc. | 2005 | — |
| −5 | K060792 | Illumimed | Photoactif, LLC | 2006 | — |
| −4 | K083183 | Aklarus Phototherapy System | Hill Laboratories Co. | 2009 | — |
| −3 | K111286 | Quasar Calypso | Silver Bay, LLC | 2012 | — |
| −2 | K162098 | LED Phototherapy Device | Li-Tek Electronic Technology Corporation | 2017 | — |
| −1 | K171821 | 2 Face / Face Evolution | Heat IN A Click | 2018 | — |
| 0 (this device) | K202055 | Looper (Model: ZX-579S) | Heat IN A Click, LLC | 2021 | — |
| +1 | K241203 | PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA… | Dongguan Hunter Electronic Technology Co., Ltd. | 2024 | — |
| +1 | K232863 | Radiant Renewal Skincare Wand (HD-15, HD-15A) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2023 | — |
| +1 | K220064 | Synergy Marble (Model: Opasm) | Yrs Group, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 10 | 0 |
| 1996 | 12 | 0 |
| 1997 | 15 | 0 |
| 1998 | 12 | 0 |
| 1999 | 5 | 0 |
| 2000 | 10 | 0 |
| 2001 | 8 | 0 |
| 2002 | 12 | 0 |
| 2003 | 10 | 0 |
| 2004 | 2 | 0 |
| 2005 | 6 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 OLP? 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 OLP device
- #1 K214103 Shani Darden LED light therapy maskscore 25.6 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K171821 | 2 Face / Face EvolutionSummary page 5…(Model:2 Name and LED Phototherapy Device Elevare Plus Face / Face Evolution) Model 510(k) K171821 K162098 K172909 Number Product NFO, OHS, OLP… | 2018 |
| * | K162098 | LED Phototherapy DeviceSummary page 5…LED Phototherapy Device Elevare Plus Face / Face Evolution) Model 510(k) K171821 K162098 K172909 Number Product NFO, OHS, OLP OLP, OHS O… | 2017 |
| * | K172909 | Elevare, Perfectio 4Summary page 5…totherapy Device Elevare Plus Face / Face Evolution) Model 510(k) K171821 K162098 K172909 Number Product NFO, OHS, OLP OLP, OHS OHS Code Regulation… | 2018 |
What descends from it? (3)
3 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 26 years and passes through 11 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 159 ancestors have a recall of any class.
- Of its descendants, K241203 (Dongguan Hunter Electronic Technology Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K171821.
How does its category compare?
All OLP devicesOLP Over-The-Counter Powered Light Based Laser For Acne: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · OLP
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLP
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLP
4in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OLP
1in 2025
MAUDE reports naming product code OLP, 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 | 1 | — | 0 | 0 |
| 2010 | 3 | 247 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 3 | 245 | 0 | 0 |
| 2014 | 3 | 255 | 0 | 1 |
| 2015 | 3 | 159 | 0 | 0 |
| 2016 | 6 | 99 | 0 | 1 |
| 2017 | 4 | 151 | 4 | 1 |
| 2018 | 5 | 104 | 0 | 7 |
| 2019 | 2 | — | 0 | 19 |
| 2020 | 1 | — | 0 | 8 |
| 2021 | 6 | 260 | 0 | 7 |
| 2022 | 5 | 245 | 0 | 1 |
| 2023 | 3 | 109 | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 3 | 88 | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Looper (Model: ZX-579S) is a hand-held device for over-the counter aesthetic purposes. The Photon mode red light is indicated for the use in treating wrinkles on the face, and the blue light is indicated for the treatment of the mild to moderate inflammatory acne.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202055 · printed Nov 3, 2026
Cite this page
510(k) Report. “K202055: Looper (Model: ZX-579S).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K202055
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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