510(k) · Cleared
ClearedLumina Intense Pulsed Light (& Laser) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lynton Lasers Limited · GEX Powered Laser Surgical Instrument
Cleared on Jul 25, 2007 as substantially equivalent to K033946 (Msq (M2), Ltd., 2004) and 1 other predicate after a 254-day review. Its family tree reaches back 9 generations to 1992.
- Decided
- Jul 25, 2007
- Review
- 254 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K910422 (1992). 154 ancestors in all, the oldest K820106 (1982). No later device cites it as a predicate yet.
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 5 generations between
- 3 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 2 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 1 generation backK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- This deviceK063427 Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited · 2007
Show all 9 generations
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 8 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 7 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 6 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 5 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 4 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 3 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 2 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 1 generation backK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- This deviceK063427 Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −8 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −7 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −6 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −5 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −4 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −3 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −2 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −1 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
| 0 (this device) | K063427 | Lumina Intense Pulsed Light (& Laser) System | Lynton Lasers Limited | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 8 | 0 |
| 1994 | 8 | 0 |
| 1995 | 8 | 0 |
| 1996 | 9 | 0 |
| 1997 | 12 | 0 |
| 1998 | 9 | 0 |
| 1999 | 7 | 0 |
| 2000 | 15 | 0 |
| 2001 | 19 | 0 |
| 2002 | 22 | 0 |
| 2003 | 14 | 0 |
| 2004 | 6 | 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? (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 |
|---|---|---|---|
| * | K033946 | Lovely SystemSummary page 1…nufactured by MSq(M2) Ltd. 7 Haeshel St. P.O.B 3021 Caesarea Industrial Park, 38900 Israel (K033946, K042000) Device Description The LUMINA Intense Pulsed Light (& Laser) System is a platform for… | 2004 |
| * | K042000 | Modified MSQ Family of Lovely Light/Laser SystemsSummary page 1…d by MSq(M2) Ltd. 7 Haeshel St. P.O.B 3021 Caesarea Industrial Park, 38900 Israel (K033946, K042000) Device Description The LUMINA Intense Pulsed Light (& Laser) System is a platform for a range… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 15 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 154 ancestors have a recall of any class.
- 8 other devices also cite its predicate K033946.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 LUMINA Intense Pulsed Light (& Laser) System is intended for use in applications requiring the selective ablation, vaporization and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialities of general & plastic surgery and dermatology, as follows· The LUMINA Intense Pulsed Light (& Laser) System, when using the IPL Handpieces, is indicated for: * The treatment of benign pigmented epidermal lesions including…
Read the full statement (394 words)
The LUMINA Intense Pulsed Light (& Laser) System is intended for use in applications requiring the selective ablation, vaporization and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialities of general & plastic surgery and dermatology, as follows·
The LUMINA Intense Pulsed Light (& Laser) System, when using the IPL Handpieces, is indicated for:
* The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation and ephelides (freckles).
* The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
* The removal of unwanted hair and to effect stable long-term or permanent hair removal.
* Indicated for use on all skin types (Fitzpatrick I-IV)
The LUMINA Intense Pulsed Light (& Laser) System, when using the internal Nd:YAG Laser Accessory at 1064nm (Long Pulsed and Q-Switched), is indicated for treatment and clearance of:
· Benign vascular lesions such as, but not limited to treatment of:
> Port wine stains
> Hemangiomas
> Superficial and deep telangiectasias (venulectasias)
> Reticular veins (0.1 - 4.0mm diameter) of the leg
> Rosacea
> Venus Lake
> Leg veins
> Spider veins
> Poikiloderma of Civatte
> Angiomas
* The removal of blue or black tattoos (significant reduction in the intensity of black and/or blue/black tattoos)
The LUMINA Intense Pulsed Light (& Laser) System, when using the internal Nd:YAG Laser Accessory at 1064nm (Long Pulsed and Q-Switched), is indicated for treatment and clearance of - continued -:
* The non-ablative treatment of facial wrinkles, such as, but not limited to:
> Periocular wrinkles
> Perioral wrinkles
* The removal of unwanted hair, for stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles.
* Removal or lightening of unwanted hair (with and without adjuvant preparation).
· Pseudofolliculitis barbae (PFB)
· Indicated for use on all skin types (Fitzpatrick -IV)
The LUMINA Intense Pulsed Light (& Laser) System, when using the internal Nd:YAG Laser Accessory at 532nm (Long Pulsed and Q-Switched), is indicated for:
* Tattoo removal:
> Light blue
> Yellow
> Red
* Benign pigmented lesions such as, but not limited to:
> Caf6 au lait macules
> Lentigines (senile and solar)
> Freckles (ephelides)
> Chloasma
> Nevi
> Nevus spillus
> Nevus of Ota
> Becker's nevi
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063427 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063427: Lumina Intense Pulsed Light (& Laser) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063427
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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