510(k) · Cleared
ClearedNO!NO! Skin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiancy (Israel), Ltd. · OLP Over-The-Counter Powered Light Based Laser For Acne
Cleared on Oct 4, 2010 as substantially equivalent to K082423 (Radiancy (Israel), Ltd., 2008) after a 35-day review. Its family tree reaches back 1 generation to 2008.
- Decided
- Oct 4, 2010
- Review
- 35 days
- Class
- Class II
- Product code
- OLP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K082423 (2008). No later device cites it as a predicate yet.
- Root · 1 generation backK082423 NO!NO! SkinRadiancy (Israel), Ltd. · 2008
- This deviceK102477 NO!NO! SkinRadiancy (Israel), Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K082423 | NO!NO! Skin | Radiancy (Israel), Ltd. | 2008 | — |
| 0 (this device) | K102477 | NO!NO! Skin | Radiancy (Israel), Ltd. | 2010 | — |
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? (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 |
|---|---|---|---|
| * | K082423 | NO!NO! SkinSummary page 1…Panel: General and Plastic Surgery Devices 7.1.7 Predicate Devices: Radiancy Ltd. nolno! SkinTm device cleared under K082423. 7.1.8 Device Description: The no!no! Skin TM device is an over the counter device employing LHE® (Light & Heat Energy) photot… | 2008 |
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?
- Its one ancestor has no recall.
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. 2010, 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?
The nolno! SkinTM is intended to provide phototherapeutic light and heat to the body and is generally indicated to treat dermatological conditions. It is specifically indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102477 · printed Nov 3, 2026
Cite this page
510(k) Report. “K102477: NO!NO! Skin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K102477
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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