510(k) · Cleared
ClearedNobleen Long Pulsed Alexandrite & Nd: YAG Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Finemec Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Nov 30, 2018 as substantially equivalent to K133283 (Candela Corp., 2013) after a 66-day review. Its family tree reaches back 11 generations to 1992.
- Decided
- Nov 30, 2018
- Review
- 66 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K910422 (1992). 65 ancestors in all, the oldest K892514 (1990). No later device cites it as a predicate yet.
- Root · 11 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 7 generations between
- 3 generations backK063074 Candela 3630 Laser SystemCandela Corp. · 2006
- 2 generations backK112715 Candela Gentlemax Family of LasersCandela Corp. · 2011
- 1 generation backK133283 Candela Gentlemax Family of Laser SystemsCandela Corp. · 2013
- This deviceK182663 Nobleen Long Pulsed Alexandrite & Nd: YAG Laser SystemFinemec Co., Ltd. · 2018
Show all 11 generations
- Root · 11 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 10 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 9 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 8 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 7 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 6 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 5 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 4 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 3 generations backK063074 Candela 3630 Laser SystemCandela Corp. · 2006
- 2 generations backK112715 Candela Gentlemax Family of LasersCandela Corp. · 2011
- 1 generation backK133283 Candela Gentlemax Family of Laser SystemsCandela Corp. · 2013
- This deviceK182663 Nobleen Long Pulsed Alexandrite & Nd: YAG Laser SystemFinemec Co., Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −10 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −9 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −8 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −7 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −6 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −5 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −4 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −3 | K063074 | Candela 3630 Laser System | Candela Corp. | 2006 | — |
| −2 | K112715 | Candela Gentlemax Family of Lasers | Candela Corp. | 2011 | — |
| −1 | K133283 | Candela Gentlemax Family of Laser Systems | Candela Corp. | 2013 | — |
| 0 (this device) | K182663 | Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System | Finemec Co., Ltd. | 2018 | — |
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 |
| 2011 | 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? (1)
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 |
|---|---|---|---|
| * | K133283 | Candela Gentlemax Family of Laser SystemsSummary page 6…on Product Code: GEX 510k Review Panel: General & Plastic Surgery 3. PREDICATE DEVICES Candela Corporation, CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS (K133283) Reference Device: FineMEC Co., LTD, Noblex Long Pulse Alexandrite Lase (K143666) Nobleen Long Pulsed Alexandrite & Nd: YAG… | 2013 |
| † | K143666 | Noblex Long Pulse Alexandrite Laser | 2015 |
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 26 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 65 ancestors have a recall of any class.
- 2 other devices also cite its predicate K133283.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
755nm The Nobleen Long Pulsed Alexandrite & Nd:YAG Laser is indicated for temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs re growing after a treatment regime. On all skin types (Fitzpatrick I- VI) including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in…
Read the full statement (322 words)
755nm
The Nobleen Long Pulsed Alexandrite & Nd:YAG Laser is indicated for temporary hair reduction.
Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs re growing after a treatment regime. On all skin types (Fitzpatrick I- VI) including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
1064nm
The Nobleen Long Pulsed Alexandrite & Nd:YAG Laser is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re growing when measured at 6, 9, and 12 months after the completion of a treatment regime. The lasers are indicated 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, hemangioma, 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 keratosis. nevi, chloasma, verrucae, skin tags, keratosis. 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/K182663 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182663: Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182663
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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