510(k) · Cleared
ClearedMyolight Microcurrent Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Raja Trading Company, Inc. · NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Cleared on Feb 10, 2025 as substantially equivalent to K232172 (BTL Industries, Inc., 2023) after a 136-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Feb 10, 2025
- Review
- 136 days
- Class
- Class II
- Product code
- NFO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K011935 (2001). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK011935 Rejuvenique Model #RJV10Salton, Inc. · 2001
- 5 generations backK072260 Nuface, Model NU-4003Carol Cole Company · 2007
- 4 generations backK103472 Nuface PlusCarol Cole Company · 2011
- 3 generations backK171588 NuBODY Skin Toning DeviceCarol Cole Company Dba Nuface · 2017
- 2 generations backK191951 Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ DeviceAvazzia, Inc. · 2021
- 1 generation backK232172 BTL-785BNF HandpieceBTL Industries, Inc. · 2023
- This deviceK243063 Myolight Microcurrent HandpieceRaja Trading Company, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K011935 | Rejuvenique Model #RJV10 | Salton, Inc. | 2001 | — |
| −5 | K072260 | Nuface, Model NU-4003 | Carol Cole Company | 2007 | — |
| −4 | K103472 | Nuface Plus | Carol Cole Company | 2011 | — |
| −3 | K171588 | NuBODY Skin Toning Device | Carol Cole Company Dba Nuface | 2017 | — |
| −2 | K191951 | Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device | Avazzia, Inc. | 2021 | — |
| −1 | K232172 | BTL-785BNF Handpiece | BTL Industries, Inc. | 2023 | — |
| 0 (this device) | K243063 | Myolight Microcurrent Handpiece | Raja Trading Company, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2018 | 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 NFO? 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 NFO device
- #1 K233010 Beagank 4T Plusscore 28.6 · 5 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.
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 24 years and passes through 6 companies; a new generation was cleared every 3.9 years on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All NFO devicesNFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · NFO
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NFO
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NFO
2in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NFO
4in 2025
MAUDE reports naming product code NFO, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 550 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 3 | 394 | 0 | 1 |
| 2012 | 3 | 160 | 2 | 0 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 5 |
| 2017 | 7 | 189 | 0 | 0 |
| 2018 | 5 | 177 | 0 | 0 |
| 2019 | 3 | 149 | 0 | 1 |
| 2020 | 2 | — | 0 | 6 |
| 2021 | 7 | 210 | 0 | 6 |
| 2022 | 2 | — | 0 | 5 |
| 2023 | 8 | 128 | 0 | 1 |
| 2024 | 5 | 109 | 0 | 4 |
| 2025 | 16 | 124 | 0 | 4 |
| 2026 | 8 | 153 | 0 | — |
What is it indicated for?
The device is indicated for aesthetic use, including facial and neck stimulation or body skin stimulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243063 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243063: Myolight Microcurrent Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243063
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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