510(k) · Cleared
ClearedBiophotas CELLUMA3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biophotas, Inc. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Sep 1, 2017 as substantially equivalent to K140471 (La Lumiere, LLC, 2015) and 2 other predicates after a 119-day review. Its family tree reaches back 13 generations to 1995. 56 later devices descend from it.
- Decided
- Sep 1, 2017
- Review
- 119 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K943450 (1995). 93 ancestors in all, the oldest K800617 (1980). 56 later devices descend from it, 7 citing it directly.
- Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 9 generations between
- 3 generations backK123999 Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013
- 2 generations backK140471 Pro X Otc 5La Lumiere, LLC · 2015
- 1 generation backK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
- This deviceK171323 Biophotas CELLUMA3Biophotas, Inc. · 2017
- Descendant · cites it directly · 46 of its ownK200983 Infrared light therapy led facial light therapy mask-Derma plus…Ningbo Hesi Electric Co., Ltd. · 2021
- Descendant · 2 generations on · 39 of its ownK223544 LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd. · 2023
- Descendant · 3 generations on · 21 of its ownK241857 LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd · 2024
- Descendant · 4 generations on · 6 of its ownK242700 Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70…Shenzhen Nuon Medical Equipment Co., Ltd. · 2024
- Descendant · cites it directly · 5 of its ownK232977 Biophotas Celluma CONTOURBiophotas, Inc. · 2023
Show all 13 generations
- Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 10 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 9 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 8 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 7 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 6 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 5 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 4 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 3 generations backK123999 Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013
- 2 generations backK140471 Pro X Otc 5La Lumiere, LLC · 2015
- 1 generation backK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
- This deviceK171323 Biophotas CELLUMA3Biophotas, Inc. · 2017
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd. · 2021 · cites it directly46descendants
- K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd. · 2023 · 2 generations on39descendants
- K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd · 2024 · 3 generations on21descendants
- K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd. · 2024 · 4 generations on6descendants
- K232977Biophotas Celluma CONTOURBiophotas, Inc. · 2023 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −12 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −10 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −9 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −8 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −7 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −6 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −5 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −4 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −3 | K123999 | Illumask Acne Light Therapy Mask | La Lumiere, LLC | 2013 | — |
| −2 | K140471 | Pro X Otc 5 | La Lumiere, LLC | 2015 | — |
| −1 | K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | Pulsaderm, LLC | 2017 | — |
| 0 (this device) | K171323 | Biophotas CELLUMA3 | Biophotas, Inc. | 2017 | — |
| +1 | K200983 | Infrared light therapy led facial light therapy mask-Derma plus, Photons… | Ningbo Hesi Electric Co., Ltd. | 2021 | — |
| +2 | K223544 | LED light therapy mask (FM-01, FM-02, FM-03) | Guangdong Newdermo Biotech Co., Ltd. | 2023 | — |
| +3 | K241857 | LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) | Dongguan Boyuan Intelligent Technology Co.,Ltd | 2024 | — |
| +4 | K242700 | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72… | Shenzhen Nuon Medical Equipment Co., Ltd. | 2024 | — |
| +1 | K232977 | Biophotas Celluma CONTOUR | Biophotas, Inc. | 2023 | — |
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 | 8 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 28 | 0 |
| 2026 | 17 | 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? (3)
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 |
|---|---|---|---|
| * | K140471 | Pro X Otc 5Summary page 6…2 K171323 Predicate devices Pro X OTC 5 Light therapy device (K140471) Pulsaderm Wrinkle mask 28 (K163329) and Lightstim for Wrinkles (K120775) The Pro X OTC 5 light therapy device, Pulsaderm Wrinkl… | 2015 |
| * | K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Summary page 6…K171323 Predicate devices Pro X OTC 5 Light therapy device (K140471) Pulsaderm Wrinkle mask 28 (K163329) and Lightstim for Wrinkles (K120775) The Pro X OTC 5 light therapy device, Pulsaderm Wrinkle mask 28, and Lightstim for wrinkle… | 2017 |
| * | K120775 | Light for WrinklesSummary page 6…K171323 Predicate devices Pro X OTC 5 Light therapy device (K140471) Pulsaderm Wrinkle mask 28 (K163329) and Lightstim for Wrinkles (K120775) The Pro X OTC 5 light therapy device, Pulsaderm Wrinkle mask 28, and Lightstim for wrinkles are all light therapy devices inten… | 2012 |
What descends from it? (56)
See all 567 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200983 | Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin… | 2021 | 46 |
| K232977 | Biophotas Celluma CONTOUR | 2023 | 5 |
| K223893 | Infrared Heat (Model: E0221) | 2023 | 5 |
| K202028 | dermalux Flex MD | 2020 | 5 |
| K223147 | myLEDmask | 2023 | 4 |
| K251042 | Light Therapy System (M500, L6) | 2025 | 1 |
| K253874 | LED Therapy Light (COB1400, HP1800PRO) | 2026 | 0 |
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 22 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 4 of the 93 ancestors have a recall of any class.
- Of its descendants, K200983 (Ningbo Hesi Electric Co., Ltd., 2021) has gone furthest, with 46 descendants of its own.
- 3 other devices also cite its predicate K140471.
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. 2017, 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 BioPhotas Celluma3 is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full face wrinkles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171323 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171323: Biophotas CELLUMA3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171323
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