510(k) · Cleared
ClearedCandela 3630 Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Candela Corp. · GEX Powered Laser Surgical Instrument
Cleared on Dec 27, 2006 as substantially equivalent to K033172 (Candela Corp., 2003) and 4 other predicates after an 82-day review. Its family tree reaches back 8 generations to 1992. 179 later devices descend from it.
- Decided
- Dec 27, 2006
- Review
- 82 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K910422 (1992). 61 ancestors in all, the oldest K892514 (1990). 179 later devices descend from it, 5 citing it directly.
- Root · 8 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 7 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 6 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 5 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 4 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 3 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 2 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 1 generation backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- This deviceK063074 Candela 3630 Laser SystemCandela Corp. · 2006
- Descendant · cites it directly · 113 of its ownK073534 Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp. · 2008
- Descendant · cites it directly · 112 of its ownK081324 Candela Family of Q-Switched Alexandrite LasersCandela Corp. · 2008
- Descendant · 2 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- Descendant · cites it directly · 90 of its ownK112715 Candela Gentlemax Family of LasersCandela Corp. · 2011
- Descendant · 3 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
Showing 5 of 179 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 179 · See all- K073534Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp. · 2008 · cites it directly113descendants
- K081324Candela Family of Q-Switched Alexandrite LasersCandela Corp. · 2008 · cites it directly112descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 2 generations on111descendants
- K112715Candela Gentlemax Family of LasersCandela Corp. · 2011 · cites it directly90descendants
- 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 |
|---|---|---|---|---|---|
| −8 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −7 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −6 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −5 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −4 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −3 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −2 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −1 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| 0 (this device) | K063074 | Candela 3630 Laser System | Candela Corp. | 2006 | — |
| +1 | K073534 | Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems | Candela Corp. | 2008 | — |
| +1 | K081324 | Candela Family of Q-Switched Alexandrite Lasers | Candela Corp. | 2008 | — |
| +2 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| +1 | K112715 | Candela Gentlemax Family of Lasers | Candela Corp. | 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 |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 7 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 8 | 0 |
| 2001 | 7 | 0 |
| 2002 | 6 | 0 |
| 2003 | 6 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 7 | 0 |
| 2015 | 7 | 0 |
| 2016 | 7 | 0 |
| 2017 | 7 | 0 |
| 2018 | 13 | 0 |
| 2019 | 8 | 0 |
| 2020 | 17 | 0 |
| 2021 | 11 | 0 |
| 2022 | 22 | 0 |
| 2023 | 15 | 0 |
| 2024 | 20 | 0 |
| 2025 | 22 | 0 |
| 2026 | 13 | 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 |
|---|---|---|---|
| * | K033172 | Candela Gentleyag Family of Laser SystemsSummary page 1…4810 Device Classification: HI Identification of Predicate Device Predicate Device(s): Candela Gentle YAG Family of Laser Systems, K033172 Candela GentleLASE Family of Laser Systems, K0243 71… | 2003 |
| * | K024371 | Candela Gentle Lase Family of Laser SystemSummary page 1…Predicate Device(s): Candela Gentle YAG Family of Laser Systems, K033172 Candela GentleLASE Family of Laser Systems, K0243 71 Candela GentleLASE Family of Laser Systems, K024335… | 2003 |
| * | K024335 | Candela Gentlelase Family of Laser SystemsSummary page 1…Candela GentleLASE Family of Laser Systems, K0243 71 Candela GentleLASE Family of Laser Systems, K024335 Candela GentleLASE Family of Laser Systems, K024260… | 2003 |
| * | K024260 | Candela Gentlelase Family of Laser SystemsSummary page 1…Candela GentleLASE Family of Laser Systems, K024335 Candela GentleLASE Family of Laser Systems, K024260 Cynosure Apogfee Elite Laser, K034030 Device Description The Candela 3630 Las… | 2003 |
| * | K034030 | Apogee EliteSummary page 1…, K024335 Candela GentleLASE Family of Laser Systems, K024260 Cynosure Apogfee Elite Laser, K034030 Device Description The Candela 3630 Laser System contains two separate laser heads (Alexandrite and Nd:YAG) wh… | 2004 |
What descends from it? (179)
See all 1795 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 61 ancestors have a recall of any class.
- Of its descendants, K073534 (Candela Corp., 2008) has gone furthest, with 113 descendants of its own.
- 9 other devices also cite its predicate K033172.
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?
755nm The Candela 3630 Laser System is indicated for the temporary hair reduction. Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. On all skin types (Fitzpatrick I-IV) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. 1064nm The Candela 3630…
Read the full statement (241 words)
755nm
The Candela 3630 Laser System is indicated for the temporary hair reduction. Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. On all skin types (Fitzpatrick I-IV) including tanned skin.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
1064nm
The Candela 3630 Laser System is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The lasers are indicted on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemoangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063074 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063074: Candela 3630 Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063074
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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