510(k) · Cleared
ClearedEpicare-Duo Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Light Age, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Nov 3, 2009 as substantially equivalent to K032991 (Light Age, Inc., 2004) and 2 other predicates after a 153-day review. Its family tree reaches back 9 generations to 1992. 1 later device descends from it.
- Decided
- Nov 3, 2009
- Review
- 153 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K910422 (1992). 68 ancestors in all, the oldest K892514 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 5 generations between
- 3 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 2 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 1 generation backK063074 Candela 3630 Laser SystemCandela Corp. · 2006
- This deviceK091625 Epicare-Duo Laser SystemLight Age, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK113115 Epicare YagLight Age, Inc. · 2012
Show all 9 generations
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 8 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 7 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 6 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 5 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 4 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 3 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 2 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 1 generation backK063074 Candela 3630 Laser SystemCandela Corp. · 2006
- This deviceK091625 Epicare-Duo Laser SystemLight Age, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K113115Epicare YagLight Age, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −8 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −7 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −6 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −5 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −4 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −3 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −2 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −1 | K063074 | Candela 3630 Laser System | Candela Corp. | 2006 | — |
| 0 (this device) | K091625 | Epicare-Duo Laser System | Light Age, Inc. | 2009 | — |
| +1 | K113115 | Epicare Yag | Light Age, Inc. | 2012 | — |
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 | 8 | 0 |
| 1998 | 6 | 0 |
| 1999 | 5 | 0 |
| 2000 | 9 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 7 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (3)
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 |
|---|---|---|---|
| * | K032991 | Light Age Epicare Alexandrite Laser, Models 501-1H, 501-SP, 501-LP and 501-LPXSummary page 1…ection 878.4810 Device Class: 1I Product Code: GEX Predicate Devices: *Light Age, Inc. EpiCareim Alexandrite Laser System [K032991), *Cynosure Apogee Elite [K034030], *Candela Corp Gentlet-ase Family of Lasers [K063074] lDcvice Descript(ion: The Light Age… | 2004 |
| * | K034030 | Apogee EliteSummary page 1…Class: 1I Product Code: GEX Predicate Devices: *Light Age, Inc. EpiCareim Alexandrite Laser System [K032991), *Cynosure Apogee Elite [K034030], *Candela Corp Gentlet-ase Family of Lasers [K063074] lDcvice Descript(ion: The Light Age EpiCare-DUOTM1 Laser is a Class IV… | 2004 |
| * | K063074 | Candela 3630 Laser SystemSummary page 1…EX Predicate Devices: *Light Age, Inc. EpiCareim Alexandrite Laser System [K032991), *Cynosure Apogee Elite [K034030], *Candela Corp Gentlet-ase Family of Lasers [K063074] lDcvice Descript(ion: The Light Age EpiCare-DUOTM1 Laser is a Class IV Laser Surgical Instrument for use in General medical/cos… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113115 | Epicare Yag | 2012 | 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 17 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 4 of the 68 ancestors have a recall of any class.
- Of its descendants, K113115 (Light Age, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K032991.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Light Age, Inc. EpiCare-DUOTM Laser System is intended for use in general and plastic surgery, dermatology, and podiatry for the treatment of vascular lesions, benign pigmented lesions, for removal of dark tattoo inks and reduction of hypertrophic and keloid scars and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hair regrowth after a treatment regime on all skin…
Read the full statement (454 words)
The Light Age, Inc. EpiCare-DUOTM Laser System is intended for use in general and
plastic surgery, dermatology, and podiatry for the treatment of vascular lesions, benign
pigmented lesions, for removal of dark tattoo inks and reduction of hypertrophic and
keloid scars and for stable long-term, or permanent hair reduction. Permanent hair
reduction is defined as long-term stable reduction in the number of hair regrowth after a
treatment regime on all skin types (Fitzpatrick I-VI including tanned skin.) No new
indications were sought in this 510(K) and no clinical data is presented.
Light Age, Inc. is providing more specialized indications which are a subset of the previously cleared indications. From both a design and clinical perspective, the predicate and candidate laser devices, are of the same technology and have the same intended use. Based upon an analysis of the overall performance characteristics for the devices, Light Age, Inc. believes that no significant differences exist.
755nm- Specifically the 755 nm mode is indicated
· Hair removal, and stable long-term or permanent hair reduction through selective
targeting of melanin in hair follicles on all skin types (Fitzpatrick I-VI) including
tanned skin. Permanent hair reduction is defined as long-term stable reduction in
the number of hair regrowth after a treatment regime. The number of hairs re-
growing must be stable over a time greater than the duration of the complete
growth cycle of hair follicles, which varies from 4-12 months according to body
location. Permanent hair reduction does not necessarily imply the elimination of
all hairs in the treated area.
* Treatment of vascular lesions
* Treatment of benign pigmented lesions.
* Treatment of wrinkles.
1064nm -
* Removal of unwanted hair, for stable long term or permanent hair reduction on all
skin types Fitzpatrick W-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 and poikiloderma of civatte. Coagulation
and hemostasis of soft tissue.
* Benign cutaneous lesions such as warts, scars striac and psoriasis.
* Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar
lentigos (sun spots), caf6 au lait macules, seborrheio keratoses, nevi, chloasma,
verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of
black and/or blue-black tattoos) and plaques.
* Pigmented lesion size reduction in patients with lesions who would potentially
benefit from aggressive treatment, and for patients with lesions that have not
responded to other laser treatments.
* Reduction of red pigmentation in hypertrophic and keloid scars where vascularity
is an integral part of the scar.
* Treatment of pseudofolliculitis barbae (PFB).
* Treatment of wrinkles including but not limited periocular wrinkles and perioral
wrinkles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091625 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091625: Epicare-Duo Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091625
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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