510(k) · Cleared
ClearedCandela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Candela Corporation · GEX Powered Laser Surgical Instrument
Cleared on Jun 1, 2023 as substantially equivalent to K183452 (Candela Corp., 2019) and 1 other predicate after a 56-day review. Its family tree reaches back 13 generations to 1992.
- Decided
- Jun 1, 2023
- Review
- 56 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K910422 (1992). 155 ancestors in all, the oldest K820106 (1982). No later device cites it as a predicate yet.
- Root · 13 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 9 generations between
- 3 generations backK133283 Candela Gentlemax Family of Laser SystemsCandela Corp. · 2013
- 2 generations backK140122 Candela Gentlemax Family of Laser SystemCandela Corp. · 2014
- 1 generation backK183452 Vbeam Prima Laser SystemCandela Corp. · 2019
- This deviceK230990 Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam…Candela Corporation · 2023
Show all 13 generations
- Root · 13 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 12 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 11 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 10 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 9 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 8 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 7 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 6 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 5 generations backK063074 Candela 3630 Laser SystemCandela Corp. · 2006
- 4 generations backK112715 Candela Gentlemax Family of LasersCandela Corp. · 2011
- 3 generations backK133283 Candela Gentlemax Family of Laser SystemsCandela Corp. · 2013
- 2 generations backK140122 Candela Gentlemax Family of Laser SystemCandela Corp. · 2014
- 1 generation backK183452 Vbeam Prima Laser SystemCandela Corp. · 2019
- This deviceK230990 Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam…Candela Corporation · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −12 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −11 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −10 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −9 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −8 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −7 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −6 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −5 | K063074 | Candela 3630 Laser System | Candela Corp. | 2006 | — |
| −4 | K112715 | Candela Gentlemax Family of Lasers | Candela Corp. | 2011 | — |
| −3 | K133283 | Candela Gentlemax Family of Laser Systems | Candela Corp. | 2013 | — |
| −2 | K140122 | Candela Gentlemax Family of Laser System | Candela Corp. | 2014 | — |
| −1 | K183452 | Vbeam Prima Laser System | Candela Corp. | 2019 | — |
| 0 (this device) | K230990 | Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) | Candela Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 7 | 0 |
| 1992 | 2 | 0 |
| 1993 | 6 | 0 |
| 1994 | 12 | 0 |
| 1995 | 8 | 0 |
| 1996 | 11 | 0 |
| 1997 | 11 | 0 |
| 1998 | 10 | 0 |
| 1999 | 7 | 0 |
| 2000 | 12 | 0 |
| 2001 | 12 | 0 |
| 2002 | 14 | 0 |
| 2003 | 10 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K183452 | Vbeam Prima Laser SystemSummary page 7…Page 22 5. LEGALLY MARKETED PREDICATE DEVICE FOR CLAIMED EQUIVALENCE: Predicate Device: Vbeam Prima Laser y System (K183452) Predicate Device: Candela Family of Pulse Laser Systems (K050673) 6. DEVICE DESCRIPTION: The Candela Vbeam Family of Pulsed… | 2019 |
| * | K050673 | Candela Family of Pulse Dye Laser SystemsSummary page 7…ARKETED PREDICATE DEVICE FOR CLAIMED EQUIVALENCE: Predicate Device: Vbeam Prima Laser y System (K183452) Predicate Device: Candela Family of Pulse Laser Systems (K050673) 6. DEVICE DESCRIPTION: The Candela Vbeam Family of Pulsed Dye Lasers includes both the Vbeam Prima and Vbeam Perfecta Laser S… | 2005 |
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 31 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 6 of the 155 ancestors have a recall of any class.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Vbeam Prima is indicated for the following: 595 nm * General Surgery: » Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions. * Dermatology/Plastic Surgery: o For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, striae and Psoriasis and the…
Read the full statement (346 words)
Vbeam Prima is indicated for the following:
595 nm
* General Surgery:
» Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions.
* Dermatology/Plastic Surgery:
o For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, striae and Psoriasis and the treatment of wrinkles.
* Treatment of Benign Epidermal Pigmented Lesions.
* Treatment of Inflammatory Acne Vulgaris.
* Gynecology:
o Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology.
* Podiatry:
o Treatment of benign cutaneous lesions, such as warts.
« Pediatric Population
o Treatment of cutaneous capillary malformations, also known as port wine stains (PWS), and infantile hemangiomas (IH) / congenital hemangiomas
1064 nm
The Vbeam Prima laser system is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, Venus lakes, leg veins, spider veins, and poikiloderma of Civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), café-au-lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, and keratoses. The laser is also indicated for the treatment of wrinkles such as, but not limited to, peri-ocular and peri-oral wrinkles.
Vbeam Perfecta is indicated for the following:
595 nm
* General Surgery:
« Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions.
* Dermatology/Plastic Surgery:
o For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, striae and Psoriasis and the treatment of wrinkles.
» Treatment of Benign Epidermal Pigmented Lesions.
» Treatment of Inflammatory Acne Vulgaris.
* Gynecology:
o Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology.
« Podiatry:
o Treatment of benign cutaneous lesions, such as warts.
« Pediatric Population
Treatment of cutaneous capillary malformations, also known as port wine stains (PWS), and infantile hemangiomas (IH) / congenital hemangiomas
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K230990 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230990: Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230990
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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