510(k) · Cleared
ClearedQuasar Calypso
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 Jan 18, 2012 as substantially equivalent to K093963 (Silver Bay, LLC, 2010) and 3 other predicates after a 257-day review. Its family tree reaches back 12 generations to 1995. 76 later devices descend from it.
- Decided
- Jan 18, 2012
- Review
- 257 days
- Class
- Class II
- Product code
- OLP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K943450 (1995). 136 ancestors in all, the oldest K800617 (1980). 76 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 8 generations between
- 3 generations backK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
- 2 generations backK060792 IllumimedPhotoactif, LLC · 2006
- 1 generation backK083183 Aklarus Phototherapy SystemHill Laboratories Co. · 2009
- This deviceK111286 Quasar CalypsoSilver Bay, LLC · 2012
- Descendant · cites it directly · 75 of its ownK162098 LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017
- Descendant · 2 generations on · 58 of its ownK171821 2 Face / Face EvolutionHeat IN A Click · 2018
- Descendant · 2 generations on · 46 of its ownK192295 PDT-FaceBeijing Adss Development Co., Ltd. · 2020
- Descendant · 3 generations on · 42 of its ownK212155 TheraFace LEDTheragun, Inc. · 2021
- Descendant · 4 generations on · 39 of its ownK223544 LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd. · 2023
Show all 12 generations
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 10 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 9 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 8 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 7 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 6 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 5 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 4 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 3 generations backK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
- 2 generations backK060792 IllumimedPhotoactif, LLC · 2006
- 1 generation backK083183 Aklarus Phototherapy SystemHill Laboratories Co. · 2009
- This deviceK111286 Quasar CalypsoSilver Bay, LLC · 2012
Showing 5 of 76 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 76 · See all- K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017 · cites it directly75descendants
- K1718212 Face / Face EvolutionHeat IN A Click · 2018 · 2 generations on58descendants
- K192295PDT-FaceBeijing Adss Development Co., Ltd. · 2020 · 2 generations on46descendants
- K212155TheraFace LEDTheragun, Inc. · 2021 · 3 generations on42descendants
- K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd. · 2023 · 4 generations on39descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −11 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −10 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −9 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −8 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −7 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −6 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −5 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −4 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −3 | K042630 | Revlight Skin Care System | Skincare Technology, Inc. | 2005 | — |
| −2 | K060792 | Illumimed | Photoactif, LLC | 2006 | — |
| −1 | K083183 | Aklarus Phototherapy System | Hill Laboratories Co. | 2009 | — |
| 0 (this device) | K111286 | Quasar Calypso | Silver Bay, LLC | 2012 | — |
| +1 | K162098 | LED Phototherapy Device | Li-Tek Electronic Technology Corporation | 2017 | — |
| +2 | K171821 | 2 Face / Face Evolution | Heat IN A Click | 2018 | — |
| +2 | K192295 | PDT-Face | Beijing Adss Development Co., Ltd. | 2020 | — |
| +3 | K212155 | TheraFace LED | Theragun, Inc. | 2021 | — |
| +4 | K223544 | LED light therapy mask (FM-01, FM-02, FM-03) | Guangdong Newdermo Biotech Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 10 | 0 |
| 1996 | 12 | 0 |
| 1997 | 15 | 0 |
| 1998 | 11 | 0 |
| 1999 | 5 | 0 |
| 2000 | 10 | 0 |
| 2001 | 7 | 0 |
| 2002 | 12 | 0 |
| 2003 | 8 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 11 | 0 |
| 2025 | 33 | 0 |
| 2026 | 16 | 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? (4)
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 |
|---|---|---|---|
| * | K093963 | Quasar Blue Light Therapy SystemSummary page 2…Device(s): This device is substantially equivalent to the following predicate devices, which are currently in safe and effective commerce: 1. K093963 - Quasar Blue Light Therapy System (Silver Bay, LLC) 2. K060792 - Illumimed (PhotoActif)l 3. K0831 83 - A… | 2010 |
| * | K060792 | IllumimedSummary page 2…predicate devices, which are currently in safe and effective commerce: 1. K093963 - Quasar Blue Light Therapy System (Silver Bay, LLC) 2. K060792 - Illumimed (PhotoActif)l 3. K0831 83 - Aklarus (Hill Labs) 4. K081307 - Omnilux Clear-U (Photo Therapeut… | 2006 |
| * | K083183 | Aklarus Phototherapy SystemSummary page 2…safe and effective commerce: 1. K093963 - Quasar Blue Light Therapy System (Silver Bay, LLC) 2. K060792 - Illumimed (PhotoActif)l 3. K0831 83 - Aklarus (Hill Labs) 4. K081307 - Omnilux Clear-U (Photo Therapeutics, LTD) 6. Technological Characteristics:… | 2009 |
| * | K081307 | Omnilux Clear-USummary page 2…093963 - Quasar Blue Light Therapy System (Silver Bay, LLC) 2. K060792 - Illumimed (PhotoActif)l 3. K0831 83 - Aklarus (Hill Labs) 4. K081307 - Omnilux Clear-U (Photo Therapeutics, LTD) 6. Technological Characteristics: The Quasar Calypso C50 has the same technol… | 2009 |
What descends from it? (76)
See all 761 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162098 | LED Phototherapy Device | 2017 | 75 |
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 17 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 136 ancestors have a recall of any class.
- Of its descendants, K162098 (Li-Tek Electronic Technology Corporation, 2017) has gone furthest, with 75 descendants of its own.
- 3 other devices also cite its predicate K093963.
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. 2012, 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 Calypso C50 is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111286 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111286: Quasar Calypso.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111286
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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