510(k) · Cleared
ClearedLMNT O2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xplr, Ltd. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Mar 24, 2025 as substantially equivalent to K232656 (Premier North America, Inc., 2023) and 1 other predicate after a 66-day review. Its family tree reaches back 14 generations to 1995.
- Decided
- Mar 24, 2025
- Review
- 66 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K943450 (1995). 111 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations between
- 3 generations backK110301 Silk'n FXHome Skinovations, Ltd. · 2011
- 2 generations backK152332 Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity · 2016
- 1 generation backK181659 Avologi ENEOPremier North America, Inc. · 2018
- This deviceK250125 LMNT O2Xplr, Ltd. · 2025
Show all 14 generations
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 10 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 9 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 8 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 7 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 6 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 5 generations backK050216 Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited · 2005
- 4 generations backK072459 Omnilux New-UPhoto Therapeutics, Inc. · 2008
- 3 generations backK110301 Silk'n FXHome Skinovations, Ltd. · 2011
- 2 generations backK152332 Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity · 2016
- 1 generation backK181659 Avologi ENEOPremier North America, Inc. · 2018
- This deviceK250125 LMNT O2Xplr, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −13 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −10 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −9 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −8 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −7 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −6 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −5 | K050216 | Omnilux Revive and Omnilux Plus | Photo Therapeutics Limited | 2005 | — |
| −4 | K072459 | Omnilux New-U | Photo Therapeutics, Inc. | 2008 | — |
| −3 | K110301 | Silk'n FX | Home Skinovations, Ltd. | 2011 | — |
| −2 | K152332 | Perfectio LED infrared device | Omm Imports Inc Dba Zero Gravity | 2016 | — |
| −1 | K181659 | Avologi ENEO | Premier North America, Inc. | 2018 | — |
| 0 (this device) | K250125 | LMNT O2 | Xplr, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 8 | 0 |
| 1995 | 9 | 0 |
| 1996 | 12 | 0 |
| 1997 | 13 | 0 |
| 1998 | 11 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 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 OHS? 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 OHS device
- #1 K223544 LED light therapy mask (FM-01, FM-02, FM-03)score 48.4 · 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? (2)
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 |
|---|---|---|---|
| * | K232656 | BLU TOTALE (Model: ENEOB852)Summary page 5…um for use in dermatology for the treatment of mild to moderate acne. 3. Predicate Device Identification Predicate 510(k) Number: K232656 Marketing clearance date: 11/14/2023 Product name: BLU TOTALE (Model: ENEOB852) Manufacturer:… | 2023 |
| * | K181659 | Avologi ENEOSummary page 5…11/14/2023 Product name: BLU TOTALE (Model: ENEOB852) Manufacturer: Premier North America Inc. Predicate 510(k) Number: K181659 Marketing clearance date: 07/26/2018… | 2018 |
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 30 years and passes through 9 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 111 ancestors have a recall of any class.
- 1 other device also cites its predicate K232656.
How does its category compare?
All OHS devicesOHS Light Based Over The Counter Wrinkle Reduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OHS
42in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OHS
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OHS
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OHS
34in 2025
MAUDE reports naming product code OHS, 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 | 2 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 176 | 0 | 0 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 4 | 310 | 0 | 1 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 5 | 168 | 0 | 1 |
| 2015 | 4 | 241 | 0 | 0 |
| 2016 | 3 | 191 | 0 | 0 |
| 2017 | 8 | 133 | 0 | 1 |
| 2018 | 7 | 84 | 0 | 1 |
| 2019 | 4 | 99 | 0 | 1 |
| 2020 | 2 | — | 0 | 2 |
| 2021 | 7 | 162 | 0 | 2 |
| 2022 | 16 | 129 | 0 | 2 |
| 2023 | 12 | 101 | 0 | 4 |
| 2024 | 16 | 87 | 0 | 5 |
| 2025 | 42 | 89 | 0 | 34 |
| 2026 | 26 | 88 | 0 | — |
What is it indicated for?
LMNT O2 is an over-the-counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. In addition, LMNT O2 indicated to emit energy in the blue region of the spectrum for use in dermatology for the treatment of mild to moderate acne.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250125 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250125: LMNT O2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250125
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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