510(k) · Cleared
ClearedFrax 1940 for Nordlys and Frax Pro
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 Dec 20, 2021 as substantially equivalent to K192951 (Ellipse A/S, 2020) and 1 other predicate after a 133-day review. Its family tree reaches back 14 generations to 1992.
- Decided
- Dec 20, 2021
- Review
- 133 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K910422 (1992). 133 ancestors in all, the oldest K820106 (1982). No later device cites it as a predicate yet.
- Root · 14 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 10 generations between
- 3 generations backK063808 Fraxel IV SR Laser SystemReliant Technologies, Inc. · 2007
- 2 generations backK130193 Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc. · 2013
- 1 generation backK192951 Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S · 2020
- This deviceK212492 Frax 1940 for Nordlys and Frax ProCandela Corporation · 2021
Show all 14 generations
- Root · 14 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 13 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 12 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 11 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 10 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 9 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 8 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 7 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 6 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 5 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 4 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 3 generations backK063808 Fraxel IV SR Laser SystemReliant Technologies, Inc. · 2007
- 2 generations backK130193 Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc. · 2013
- 1 generation backK192951 Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S · 2020
- This deviceK212492 Frax 1940 for Nordlys and Frax ProCandela Corporation · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −13 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −12 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −11 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −10 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −9 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −8 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −7 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −6 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −5 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −4 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −3 | K063808 | Fraxel IV SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −2 | K130193 | Fraxel Dual 1550/1927 Laser System | Solta Medical, Inc. | 2013 | — |
| −1 | K192951 | Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun | Ellipse A/S | 2020 | — |
| 0 (this device) | K212492 | Frax 1940 for Nordlys and Frax Pro | Candela Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1993 | 5 | 0 |
| 1994 | 12 | 0 |
| 1995 | 9 | 0 |
| 1996 | 12 | 0 |
| 1997 | 10 | 0 |
| 1998 | 9 | 0 |
| 1999 | 7 | 0 |
| 2000 | 11 | 0 |
| 2001 | 9 | 0 |
| 2002 | 11 | 0 |
| 2003 | 9 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K192951 | Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunSummary page 5…Product Code: GEX 5. LEGALLY MARKETED PREDICATE DEVICE FOR CLAIMED EQUIVALENCE: Predicate Device: Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun (K192951) Co-predicate Device: Fraxel Dual 1550/1927 Laser System (K130193)… | 2020 |
| * | K130193 | Fraxel Dual 1550/1927 Laser SystemSummary page 5…D EQUIVALENCE: Predicate Device: Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun (K192951) Co-predicate Device: Fraxel Dual 1550/1927 Laser System (K130193) 1 6. DEVIC… | 2013 |
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 29 years and passes through 9 companies; a new generation was cleared every 1.7 years on median.
- 6 of the 133 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. 2021, 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?
Nordlys system is intended to be used in dermatology as listed below: Nordlys System + Intense pulse light applicators: * Permanent Hair Reduction (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 regimen) (overall 600 - 950 nm). * Treatment of Telangiectasias (530-750 nm or 555-950 nm) * Treatment of Port Wine Stains (530-750 nm or 555-950 nm) *…
Read the full statement (417 words)
Nordlys system is intended to be used in dermatology as listed below:
Nordlys System + Intense pulse light applicators:
* Permanent Hair Reduction (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 regimen) (overall 600 - 950 nm).
* Treatment of Telangiectasias (530-750 nm or 555-950 nm)
* Treatment of Port Wine Stains (530-750 nm or 555-950 nm)
* Treatment of Benign Pigmented Lesions (eg Mottled Pigmentation, Ephelides) and Benign Vascular Lesions (eg Diffuse Redness) (530-750 nm or 555-950 nm)
* Treatment of Rosacea (530-750 nm or 555-950 nm)
* Treatment of Poikiloderma of Civatte (530-750 nm or 555-950 nm)
* Treatment of Benign Epidermal Pigmented Lesions (eg Solar Lentigines ) (400-720 nm)
* Treatment of Inflammatory Acne Vulgaris (530-750 nm)
Nordlys System + Nd:YAG Laser (1064 nm):
*Treatment of Leg Vessels (0.1-3.0 mm diameter).
* Treatment of Benign Vascular Lesions.
* Treatment of Venous Lakes.
* Treatment of Port Wine Stains.
* Treatment for Clear Nail defined as: Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
* Treatment of benign cutaneous lesions, such as warts.
Podiatry (ablation, vaporization, incision, and coagulation of soft tissue), including:
- Matrixectomy
- Periungal and subungal warts
- Plantar warts.
Nordlys System + Frax 1940 Laser (1940 nm):
* The Frax 1940 is indicated for use in dermatological procedures requiring the coagulation of soft tissue and for skin resurfacing procedures.
Frax 1940 is indicated for treatment of benign pigmented lesions, such as but not limited to lentigines (age spots), solar lentigines (sunspots), and ephelides (freckles) for Fitzpatrick Skin Types I-IV.
Nordlys System + Frax 1550 Laser (1550 nm):
*The Frax 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.
Frax Pro system (Ydun) is intended to be used in dermatology, as listed below:
* The Frax 1940 is indicated for use in dermatological procedures requiring the coagulation of soft tissue and for skin resurfacing procedures.
Frax 1940 is indicated for treatment of benign pigmented lesions, such as but not limited to lentigines (age spots), solar lentigines (sunspots), and ephelides (freckles) for Fitzpatrick Skin Types I-IV.
Frax Pro System + Frax 1550 (1550 nm)
*The Frax 1550nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.
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/K212492 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212492: Frax 1940 for Nordlys and Frax Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212492
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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