510(k) · Cleared
ClearedDermillume, Model PRO1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Care Electronics, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Feb 24, 2005 as substantially equivalent to K013623 (Curelight, Ltd., 2002) and 3 other predicates after a 59-day review. Its family tree reaches back 9 generations to 1995. 4 later devices descend from it.
- Decided
- Feb 24, 2005
- Review
- 59 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K943450 (1995). 86 ancestors in all, the oldest K800617 (1980). 4 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 5 generations between
- 3 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 2 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 1 generation backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- This deviceK043575 Dermillume, Model PRO1000Care Electronics, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK051681 Dermillume Red, Model HR1000Care Electronics, Inc. · 2005
- Descendant · 2 generations on · 1 of its ownK081570 DPL Therapy SystemLed Technologies, LLC · 2008 · Recalled
- Descendant · 3 generations on · 0 of its ownK150554 NuBrilliance Light Pain TherapyWellquest International, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK070690 The Life VesselCottonwood Vessel Corporation · 2007
Show all 9 generations
- Root · 9 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 8 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 7 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 6 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 5 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 4 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 3 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 2 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 1 generation backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- This deviceK043575 Dermillume, Model PRO1000Care Electronics, Inc. · 2005
Most influential descendants
Showing 4 of 4 · See all- K051681Dermillume Red, Model HR1000Care Electronics, Inc. · 2005 · cites it directly3descendants
- K081570DPL Therapy SystemLed Technologies, LLC · 2008 · 2 generations on1descendant
- K150554NuBrilliance Light Pain TherapyWellquest International, Inc. · 2015 · 3 generations on0descendants
- K070690The Life VesselCottonwood Vessel Corporation · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −8 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −7 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −6 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −5 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −4 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −3 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −2 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −1 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| 0 (this device) | K043575 | Dermillume, Model PRO1000 | Care Electronics, Inc. | 2005 | — |
| +1 | K051681 | Dermillume Red, Model HR1000 | Care Electronics, Inc. | 2005 | — |
| +2 | K081570 | DPL Therapy System | Led Technologies, LLC | 2008 | 1 |
| +3 | K150554 | NuBrilliance Light Pain Therapy | Wellquest International, Inc. | 2015 | — |
| +2 | K070690 | The Life Vessel | Cottonwood Vessel Corporation | 2007 | — |
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 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2015 | 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 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 |
|---|---|---|---|
| * | K013623 | Clearlight Phototheraphy System, Model CL 420Summary page 1…eral and Plastic Surgery and in Dermatology. Product code: SEX Predicate Devices: ClearLight, Phototherapy System, Model Cl 420 (K013623), BLU- U, Model 4710 (KO031805), Omnilux Blue (K(030883), & Omnilux R… | 2002 |
| * | K031805 | Blu-U, Model 4170Summary page 2…the same as the predicate devices, ClearLight, Phototherapy System, Model Cl 420 (KOl 3623), BLU-U, Model 471 0 (K031805), Omnilux Blue (K030883) for the reduction and elimination of the acne-producing bacterium P. acnes.… | 2003 |
| * | K030883 | Omnilux BlueSummary page 2…te devices, ClearLight, Phototherapy System, Model Cl 420 (KOl 3623), BLU-U, Model 471 0 (K031805), Omnilux Blue (K030883) for the reduction and elimination of the acne-producing bacterium P. acnes.… | 2003 |
| * | K030426 | Omnilux RedSummary page 2…l acne treatment study. The output wavelength and irradiance are comparable to the predicate device, Omnilux Red (K030426). There are no significant adverse reactions observed in clinical studies… | 2003 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051681 | Dermillume Red, Model HR1000 | 2005 | 3 |
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 10 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 3 of the 86 ancestors have a recall of any class.
- Of its descendants, K051681 (Care Electronics, Inc., 2005) has gone furthest, with 3 descendants of its own.
- 9 other devices also cite its predicate K013623.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The Dermillume Pro1000 phototherapy lamp is intended for dermatological use by trained licensed practitioners, specifically for the treatment of mild to moderate inflammatory acne vulgaris.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043575 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043575: Dermillume, Model PRO1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043575
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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