510(k) · Cleared
Recalled · Class II · 2018Quasar C100, Baby Quasar Plus, Quasar MD Plus; Wrinkle Reduction Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Silverbay, LLC, D/B/A Quasar Bio-Tech · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Jul 11, 2013 after a 163-day review. The FDA summary names no predicate by number. 108 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 11, 2013
- Review
- 163 days
- Class
- Class II
- Product code
- OHS
- Recalls
- 3
- Predicates
- 0
108 later devices descend from it, 2 citing it directly.
- This deviceK130225 Quasar C100, Baby Quasar Plus, Quasar MD Plus; Wrinkle Reduction…Silverbay, LLC, D/B/A Quasar Bio-Tech · 2013
- Descendant · cites it directly · 106 of its ownK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
- Descendant · 2 generations on · 93 of its ownK170984 LG Beauty Led MaskLg Electronics · 2017
- Descendant · 3 generations on · 71 of its ownK191629 faceLITEIsmart Marketing Svcs, Ltd. · 2019
- Descendant · 2 generations on · 56 of its ownK171323 Biophotas CELLUMA3Biophotas, Inc. · 2017
- Descendant · 3 generations on · 48 of its ownK183671 LG Pra.L Derma Led MaskLg Electronics.Inc · 2019
Showing 5 of 108 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 108 · See all- K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017 · cites it directly106descendants
- K170984LG Beauty Led MaskLg Electronics · 2017 · 2 generations on93descendants
- K191629faceLITEIsmart Marketing Svcs, Ltd. · 2019 · 3 generations on71descendants
- K171323Biophotas CELLUMA3Biophotas, Inc. · 2017 · 2 generations on56descendants
- K183671LG Pra.L Derma Led MaskLg Electronics.Inc · 2019 · 3 generations on48descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K130225 | Quasar C100, Baby Quasar Plus, Quasar MD Plus; Wrinkle Reduction Device | Silverbay, LLC, D/B/A Quasar Bio-Tech | 2013 | — |
| +1 | K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | Pulsaderm, LLC | 2017 | — |
| +2 | K170984 | LG Beauty Led Mask | Lg Electronics | 2017 | — |
| +3 | K191629 | faceLITE | Ismart Marketing Svcs, Ltd. | 2019 | — |
| +2 | K171323 | Biophotas CELLUMA3 | Biophotas, Inc. | 2017 | — |
| +3 | K183671 | LG Pra.L Derma Led Mask | Lg Electronics.Inc | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 8 | 0 |
| 2023 | 11 | 0 |
| 2024 | 11 | 0 |
| 2025 | 43 | 0 |
| 2026 | 21 | 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?
The FDA summary names no predicate by number.
What descends from it? (108)
See all 1082 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 29, 2018 | Class II | Z-2973-2018 | Under Investigation by firm | Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals. |
| Jun 29, 2018 | Class II | Z-2975-2018 | Under Investigation by firm | Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals. |
| Jun 29, 2018 | Class II | Z-2974-2018 | Under Investigation by firm | Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K163329 (Pulsaderm, LLC, 2017) has gone furthest, with 106 descendants of its own.
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. 2013, 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?
The Quasar C100 Wrinkle Reduction Device is intended to emit energy in the red and IR region of the spectrum, specifically indicated for the treatment of full-face wrinkles.
The Baby Quasar Plus Wrinkle Reduction Device is intended to emit energy in the red and IR region of the spectrum, specifically indicated for the treatment of full-face wrinkles.
The Quasar MD Plus Wrinkle Reduction Device is intended to emit energy in the red and IR region of the spectrum, specifically indicated for the treatment of full-face wrinkles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130225 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130225: Quasar C100, Baby Quasar Plus, Quasar MD Plus; Wrinkle Reduction Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130225
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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