510(k) · Cleared
Cleared15W Ceralas D 1470NM Diode Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolitec, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Feb 27, 2008 as substantially equivalent to K040921 (Cooltouch, Inc., 2004) and 4 other predicates after a 120-day review. Its family tree reaches back 10 generations to 1992. 202 later devices descend from it.
- Decided
- Feb 27, 2008
- Review
- 120 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K910422 (1992). 258 ancestors in all, the oldest K771218 (1978). 202 later devices descend from it, 7 citing it directly.
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 6 generations between
- 3 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 2 generations backK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- 1 generation backK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- This deviceK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
- Descendant · cites it directly · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- Descendant · cites it directly · 177 of its ownK090164 Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009
- Descendant · cites it directly · 112 of its ownK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- Descendant · 2 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- Descendant · 3 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
Show all 10 generations
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 9 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 8 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 7 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 6 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 5 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 4 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 3 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 2 generations backK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- 1 generation backK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- This deviceK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
Showing 5 of 202 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 202 · See all- K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · cites it directly192descendants
- K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009 · cites it directly177descendants
- K082230Vectra Plus Laser System and AccessoriesXintec Corporation · 2010 · cites it directly112descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 2 generations on111descendants
- K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 3 generations on70descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −9 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −8 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −7 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −6 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −5 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −4 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −3 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −2 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
| −1 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| 0 (this device) | K073063 | 15W Ceralas D 1470NM Diode Laser | Biolitec, Inc. | 2008 | — |
| +1 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| +1 | K090164 | Ceralas Multiwavelength 980/1470NM Diode Laser | Biolitec, Inc. | 2009 | — |
| +1 | K082230 | Vectra Plus Laser System and Accessories | Xintec Corporation | 2010 | — |
| +2 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| +3 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 6 | 0 |
| 1992 | 2 | 0 |
| 1993 | 11 | 0 |
| 1994 | 15 | 0 |
| 1995 | 15 | 0 |
| 1996 | 20 | 0 |
| 1997 | 24 | 0 |
| 1998 | 20 | 0 |
| 1999 | 16 | 0 |
| 2000 | 21 | 0 |
| 2001 | 24 | 0 |
| 2002 | 27 | 0 |
| 2003 | 20 | 0 |
| 2004 | 9 | 0 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 6 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 7 | 0 |
| 2014 | 9 | 0 |
| 2015 | 10 | 0 |
| 2016 | 10 | 0 |
| 2017 | 6 | 0 |
| 2018 | 11 | 0 |
| 2019 | 7 | 0 |
| 2020 | 14 | 0 |
| 2021 | 9 | 0 |
| 2022 | 23 | 0 |
| 2023 | 13 | 0 |
| 2024 | 23 | 0 |
| 2025 | 28 | 0 |
| 2026 | 15 | 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? (5)
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 |
|---|---|---|---|
| * | K040921 | Cooltouch, Model NS 160Summary page 1…A 01028 Common or Usual Name Diode Laser Classification Name Laser, Surgical Diode Laser System Predicate Devices CoolTouch Model CT3S Nd:YAG laser (K040921) CoolTouch CTEV and OT3S 1320 Nd:YAG laser (K051434) CoolTouch CTEV Nd:YAG laser (K061618) CoolTouch LC160 CTEV Nd… | 2004 |
| * | K051434 | Cooltouch ND:Yag Laser Systems, Models CT3S and CtevSummary page 1…cation Name Laser, Surgical Diode Laser System Predicate Devices CoolTouch Model CT3S Nd:YAG laser (K040921) CoolTouch CTEV and OT3S 1320 Nd:YAG laser (K051434) CoolTouch CTEV Nd:YAG laser (K061618) CoolTouch LC160 CTEV Nd:YAG laser (K0622 10) Sciton, Inc., Profile Multi-Pl… | 2005 |
| * | K061618 | Cooltouch, Model CtevSummary page 1…er System Predicate Devices CoolTouch Model CT3S Nd:YAG laser (K040921) CoolTouch CTEV and OT3S 1320 Nd:YAG laser (K051434) CoolTouch CTEV Nd:YAG laser (K061618) CoolTouch LC160 CTEV Nd:YAG laser (K0622 10) Sciton, Inc., Profile Multi-Platform System (K(060033) In… | 2006 |
| * | K062210 | Cool Touch, Models CT3S, Ctev, NS160, Ctev, LC160Summary page 1…l CT3S Nd:YAG laser (K040921) CoolTouch CTEV and OT3S 1320 Nd:YAG laser (K051434) CoolTouch CTEV Nd:YAG laser (K061618) CoolTouch LC160 CTEV Nd:YAG laser (K0622 10) Sciton, Inc., Profile Multi-Platform System (K(060033) Intended Use / Indications for Use The Ceralas… | 2006 |
| * | K060033 | Profile Multi-Platform SystemSummary page 1…0 Nd:YAG laser (K051434) CoolTouch CTEV Nd:YAG laser (K061618) CoolTouch LC160 CTEV Nd:YAG laser (K0622 10) Sciton, Inc., Profile Multi-Platform System (K(060033) Intended Use / Indications for Use The Ceralas D1470 is a diode laser that is intended for delivery of las… | 2006 |
What descends from it? (202)
See all 2027 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083613 | Quanta System Polysurge Diode Laser Family | 2008 | 192 |
| K090164 | Ceralas Multiwavelength 980/1470NM Diode Laser | 2009 | 177 |
| K082230 | Vectra Plus Laser System and Accessories | 2010 | 112 |
| K112253 | Ceralas 147NM Diode Laser System | 2011 | 18 |
| K110364 | Dornier Medilas D Litebeam+ 1470 | 2011 | 7 |
| K212734 | Diode laser therapy device | 2023 | 5 |
| K212733 | Diode laser therapy device | 2023 | 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 16 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 12 of the 258 ancestors have a recall of any class.
- Of its descendants, K083613 (Quanta System Spa, 2008) has gone furthest, with 192 descendants of its own.
- 1 other device also cites its predicate K040921.
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 Ceralas D1470 is a diode laser that is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures. The device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073063 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073063: 15W Ceralas D 1470NM Diode Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073063
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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