510(k) · Cleared
ClearedPhotonova Family of Pulsed Light Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Photonova Ofsweden AB · GEX Powered Laser Surgical Instrument
Cleared on May 9, 2008 as substantially equivalent to K032191 (Luxsano AB, 2003) and 1 other predicate after a 150-day review. Its family tree reaches back 7 generations to 1992. 3 later devices descend from it.
- Decided
- May 9, 2008
- Review
- 150 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K910422 (1992). 25 ancestors in all, the oldest K892514 (1990). 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 6 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 5 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 4 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 3 generations backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 2 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 1 generation backK032191 Omnilight Fluorescent Pulsed Light SystemLuxsano AB · 2003
- This deviceK073477 Photonova Family of Pulsed Light SystemsPhotonova Ofsweden AB · 2008
- Descendant · cites it directly · 2 of its ownK092734 E-Light LineEspansione Marketing S.P.A · 2010
- Descendant · 2 generations on · 1 of its ownK124064 Young AgainEspansione Marketing S.P.A · 2013
- Descendant · 3 generations on · 0 of its ownK162556 Lightfusion Led SystemVitage Led, Ltd. · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −6 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −5 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −4 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −3 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −2 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −1 | K032191 | Omnilight Fluorescent Pulsed Light System | Luxsano AB | 2003 | — |
| 0 (this device) | K073477 | Photonova Family of Pulsed Light Systems | Photonova Ofsweden AB | 2008 | — |
| +1 | K092734 | E-Light Line | Espansione Marketing S.P.A | 2010 | — |
| +2 | K124064 | Young Again | Espansione Marketing S.P.A | 2013 | — |
| +3 | K162556 | Lightfusion Led System | Vitage Led, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032191 | Omnilight Fluorescent Pulsed Light SystemSummary page 1…Instrument, Surgical, Powered, laser 79-GEX, 21 CFR 878-48 Legally Marketed Predicate Device: OmniLight K032191 Lux V K040081 StarLux K03… | 2003 |
| * | K040081 | Palomar Luxv HandpieceSummary page 1…79-GEX, 21 CFR 878-48 Legally Marketed Predicate Device: OmniLight K032191 Lux V K040081 StarLux K03349 Description of the Photonova Family of The Photonova Puls… | 2004 |
| Kept off the family tree | K033349 | FDA’s K033349 is AC-1 SP02 Adaptor Cable, Model AC-1 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2004 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092734 | E-Light Line | 2010 | 2 |
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 16 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- None of the 25 ancestors has a recall.
- Of its descendants, K092734 (Espansione Marketing S.P.A, 2010) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K032191.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 PhotoNova Family of Pulsed Light Systems is designed for use in dermatology applications including:
· The removal of unwanted hair form all skin types and to effect stable long-term or permanent hair reduction
· The treatment of benign pigmented lesions, including lentigines, nevi, melasma and caf6-au-lait
* The treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, ttelangiectasias, rosacea, facial and leg veins
· Treatment of inflammatory acne (acne vulgaris)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073477 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073477: Photonova Family of Pulsed Light Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073477
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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