510(k) · Cleared
ClearedSapphire, Elevare Sapphire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omm Imports, Inc. D/B/A Zero Gravity · OLP Over-The-Counter Powered Light Based Laser For Acne
Cleared on May 1, 2018 as substantially equivalent to K121435 (Home Skinovations, Ltd., 2013) and 1 other predicate after a 250-day review. Its family tree reaches back 12 generations to 1995. 52 later devices descend from it.
- Decided
- May 1, 2018
- Review
- 250 days
- Class
- Class II
- Product code
- OLP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K943450 (1995). 98 ancestors in all, the oldest K800617 (1980). 52 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 8 generations between
- 3 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 2 generations backK121435 Silkn BlueHome Skinovations, Ltd. · 2013
- 1 generation backK131461 Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC · 2014
- This deviceK172555 Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity · 2018
- Descendant · cites it directly · 46 of its ownK192295 PDT-FaceBeijing Adss Development Co., Ltd. · 2020
- Descendant · 2 generations on · 39 of its ownK202390 Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd. · 2021
- Descendant · 3 generations on · 34 of its ownK220168 Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd. · 2022
- Descendant · 4 generations on · 33 of its ownK230351 LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd. · 2023
- Descendant · 5 generations on · 21 of its ownK241857 LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd · 2024
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 backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 2 generations backK121435 Silkn BlueHome Skinovations, Ltd. · 2013
- 1 generation backK131461 Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC · 2014
- This deviceK172555 Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity · 2018
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K192295PDT-FaceBeijing Adss Development Co., Ltd. · 2020 · cites it directly46descendants
- K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd. · 2021 · 2 generations on39descendants
- K220168Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd. · 2022 · 3 generations on34descendants
- K230351LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd. · 2023 · 4 generations on33descendants
- K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd · 2024 · 5 generations on21descendants
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 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −2 | K121435 | Silkn Blue | Home Skinovations, Ltd. | 2013 | — |
| −1 | K131461 | Lightstim for Acne/ Lightstim for Acne Mini | Led Intellectual Properties, LLC | 2014 | — |
| 0 (this device) | K172555 | Sapphire, Elevare Sapphire | Omm Imports, Inc. D/B/A Zero Gravity | 2018 | — |
| +1 | K192295 | PDT-Face | Beijing Adss Development Co., Ltd. | 2020 | — |
| +2 | K202390 | Aduro Light Beauty Mask | Shenzhen Kaiyan Medical CO, Ltd. | 2021 | — |
| +3 | K220168 | Skin Care Beauty Mask (Model: MJ-06) | Shenzhen Kaiyan Medical CO, Ltd. | 2022 | — |
| +4 | K230351 | LED Facial Mask | Shenzhen Sungpo Hi-Tech Electronic Co., Ltd. | 2023 | — |
| +5 | K241857 | LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) | Dongguan Boyuan Intelligent Technology Co.,Ltd | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 8 | 0 |
| 1995 | 9 | 0 |
| 1996 | 12 | 0 |
| 1997 | 13 | 0 |
| 1998 | 9 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 8 | 0 |
| 2025 | 26 | 0 |
| 2026 | 10 | 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? (2)
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 |
|---|---|---|---|
| * | K121435 | Silkn BlueSummary page 4…Proprietary Names: Sapphire 2.4 Classification: Class II 2.5 Classification Number: 878.4810 2.6 Product Code: OLP 3. Predicate Device(s): Primary Predicate Device: K121435 – Silk’n Blue (Home Skinovations LTD) Secondary Predicate Device: K131461 – LightStim for Acne Mini (LED Intellectual Properties… | 2013 |
| * | K131461 | Lightstim for Acne/ Lightstim for Acne MiniSummary page 4…tion Number: 878.4810 2.6 Product Code: OLP 3. Predicate Device(s): Primary Predicate Device: K121435 – Silk’n Blue (Home Skinovations LTD) Secondary Predicate Device: K131461 – LightStim for Acne Mini (LED Intellectual Properties LLC) 4. Device Description: The Sapphire device is an o… | 2014 |
What descends from it? (52)
See all 523 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?
- The line of descent spans 23 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 98 ancestors have a recall of any class.
- Of its descendants, K192295 (Beijing Adss Development Co., Ltd., 2020) has gone furthest, with 46 descendants of its own.
- 7 other devices also cite its predicate K121435.
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. 2018, 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 SAPPHIRE is an over –the -counter hand held, battery operated, light therapy device that uses light emitting diodes (LEDs) that emit a specific wavelength of 415nm (Blue Light) that is intended for use in the treatment of mild to moderate inflammatory acne.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172555 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172555: Sapphire, Elevare Sapphire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172555
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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