510(k) · Cleared
ClearedCryoGlow (FW3XXXX)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sharkninja Operating, LLC · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Nov 27, 2024 as substantially equivalent to K230293 (Therabody, Inc., 2023) after a 72-day review. Its family tree reaches back 17 generations to 1995. 4 later devices descend from it.
- Decided
- Nov 27, 2024
- Review
- 72 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K943450 (1995). 167 ancestors in all, the oldest K800617 (1980). 4 later devices descend from it, 2 citing it directly.
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations between
- 3 generations backK191629 faceLITEIsmart Marketing Svcs, Ltd. · 2019
- 2 generations backK213184 MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin · 2021
- 1 generation backK230293 TheraFace MaskTherabody, Inc. · 2023
- This deviceK242796 CryoGlow (FW3XXXX)Sharkninja Operating, LLC · 2024
- Descendant · cites it directly · 2 of its ownK251588 LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908…Shenzhen Fittop Health Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK260715 CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK253054 LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK252994 LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4…Guangdong Ace-Tec Co., Ltd. · 2025
Show all 17 generations
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 13 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 11 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 10 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 9 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 8 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 7 generations backK123999 Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013
- 6 generations backK140471 Pro X Otc 5La Lumiere, LLC · 2015
- 5 generations backK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
- 4 generations backK170984 LG Beauty Led MaskLg Electronics · 2017
- 3 generations backK191629 faceLITEIsmart Marketing Svcs, Ltd. · 2019
- 2 generations backK213184 MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin · 2021
- 1 generation backK230293 TheraFace MaskTherabody, Inc. · 2023
- This deviceK242796 CryoGlow (FW3XXXX)Sharkninja Operating, LLC · 2024
Most influential descendants
Showing 4 of 4 · See all- K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd. · 2025 · cites it directly2descendants
- K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd. · 2026 · 2 generations on0descendants
- K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. · 2025 · 2 generations on0descendants
- K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −16 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −13 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −11 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −10 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −9 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −8 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −7 | K123999 | Illumask Acne Light Therapy Mask | La Lumiere, LLC | 2013 | — |
| −6 | K140471 | Pro X Otc 5 | La Lumiere, LLC | 2015 | — |
| −5 | K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | Pulsaderm, LLC | 2017 | — |
| −4 | K170984 | LG Beauty Led Mask | Lg Electronics | 2017 | — |
| −3 | K191629 | faceLITE | Ismart Marketing Svcs, Ltd. | 2019 | — |
| −2 | K213184 | MZ Skin LightMAX Supercharged LED Mask 2.0 | Mz Skin | 2021 | — |
| −1 | K230293 | TheraFace Mask | Therabody, Inc. | 2023 | — |
| 0 (this device) | K242796 | CryoGlow (FW3XXXX) | Sharkninja Operating, LLC | 2024 | — |
| +1 | K251588 | LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) | Shenzhen Fittop Health Technology Co., Ltd. | 2025 | — |
| +2 | K260715 | CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) | The Beauty Tech Group, Ltd. | 2026 | — |
| +2 | K253054 | LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) | Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. | 2025 | — |
| +1 | K252994 | LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5… | Guangdong Ace-Tec Co., Ltd. | 2025 | — |
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 | 12 | 0 |
| 1999 | 5 | 0 |
| 2000 | 10 | 0 |
| 2001 | 7 | 0 |
| 2002 | 12 | 0 |
| 2003 | 10 | 0 |
| 2004 | 2 | 0 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 3 | 0 |
| 2026 | 1 | 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? (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 |
|---|---|---|---|
| * | K230293 | TheraFace MaskSummary page 5…ass II Review Panel: General & Plastic Surgery Regulation 21 CFR 878.4810 Number: Product Code: OHS, OLP Predicate TheraFace Device: K230293 Product codes OHS, OLP 21 CFR 878.4810 Class II Reference MZ Skin… | 2023 |
| † | K213184 | MZ Skin LightMAX Supercharged LED Mask 2.0 | 2021 |
What descends from it? (4)
2 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 29 years and passes through 12 companies; a new generation was cleared every 1.4 years on median.
- 6 of the 167 ancestors have a recall of any class.
- Of its descendants, K251588 (Shenzhen Fittop Health Technology Co., Ltd., 2025) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K230293.
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. 2024, 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 CryoGlow LED mask emits energy in the red and infrared light spectrum for the treatment of fine lines and wrinkles and in the red, blue, and infrared light spectrum for the treatment of mild-to-moderate inflammatory acne.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242796 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242796: CryoGlow (FW3XXXX).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242796
Report an extraction error
Are you the manufacturer?
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