510(k) · Cleared
ClearedQuasar Blue Light Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Silver Bay, LLC · OLP Over-The-Counter Powered Light Based Laser For Acne
Cleared on Aug 27, 2010 as substantially equivalent to K072767 (Silver Bay, LLC, 2007) after a 247-day review. Its family tree reaches back 1 generation to 2007. 130 later devices descend from it.
- Decided
- Aug 27, 2010
- Review
- 247 days
- Class
- Class II
- Product code
- OLP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K072767 (2007). 130 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK072767 Quasar Blue Light Therapy SystemSilver Bay, LLC · 2007
- This deviceK093963 Quasar Blue Light Therapy SystemSilver Bay, LLC · 2010
- Descendant · cites it directly · 125 of its ownK121435 Silkn BlueHome Skinovations, Ltd. · 2013
- Descendant · cites it directly · 81 of its ownK131461 Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC · 2014
- Descendant · cites it directly · 76 of its ownK111286 Quasar CalypsoSilver Bay, LLC · 2012
- Descendant · 2 generations on · 75 of its ownK162098 LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017
- Descendant · 3 generations on · 58 of its ownK171821 2 Face / Face EvolutionHeat IN A Click · 2018
Showing 5 of 130 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 130 · See all- K121435Silkn BlueHome Skinovations, Ltd. · 2013 · cites it directly125descendants
- K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC · 2014 · cites it directly81descendants
- K111286Quasar CalypsoSilver Bay, LLC · 2012 · cites it directly76descendants
- K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017 · 2 generations on75descendants
- K1718212 Face / Face EvolutionHeat IN A Click · 2018 · 3 generations on58descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K072767 | Quasar Blue Light Therapy System | Silver Bay, LLC | 2007 | — |
| 0 (this device) | K093963 | Quasar Blue Light Therapy System | Silver Bay, LLC | 2010 | — |
| +1 | K121435 | Silkn Blue | Home Skinovations, Ltd. | 2013 | — |
| +1 | K131461 | Lightstim for Acne/ Lightstim for Acne Mini | Led Intellectual Properties, LLC | 2014 | — |
| +1 | K111286 | Quasar Calypso | Silver Bay, LLC | 2012 | — |
| +2 | K162098 | LED Phototherapy Device | Li-Tek Electronic Technology Corporation | 2017 | — |
| +3 | K171821 | 2 Face / Face Evolution | Heat IN A Click | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 8 | 0 |
| 2022 | 10 | 0 |
| 2023 | 12 | 0 |
| 2024 | 14 | 0 |
| 2025 | 41 | 0 |
| 2026 | 20 | 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 25.5 · 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 |
|---|---|---|---|
| * | K072767 | Quasar Blue Light Therapy SystemSummary page 1…tem for home use is identical to the company's previously cleared Quasar Blue Light Therapy System (K072767). Only the Operators Manual. and the Patient Treatment Protocol have been modified to… | 2007 |
What descends from it? (130)
See all 1304 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?
- Its one ancestor has no recall.
- Of its descendants, K121435 (Home Skinovations, Ltd., 2013) has gone furthest, with 125 descendants of its own.
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 "Quasar Blue" Blue Light Therapy System is intended to provide photo therapeutic
light to the body. The 'Quasar Blue" Blue Light Therapy System is generally indicated to
treat dermatological conditions. The 'Quasar Blue" Blue Light Therapy System is
specifically indicated to emit visible blue/violet light to treat mild to moderate
inflammatory acne vulgaris.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093963 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093963: Quasar Blue Light Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093963
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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