510(k) · Cleared
ClearedEpicare Yag
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 Apr 3, 2012 as substantially equivalent to K091625 (Light Age, Inc., 2009) and 2 other predicates after a 165-day review. Its family tree reaches back 10 generations to 1992.
- Decided
- Apr 3, 2012
- Review
- 165 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K910422 (1992). 69 ancestors in all, the oldest K892514 (1990). No later device cites it as a predicate yet.
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 6 generations between
- 3 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 2 generations backK063074 Candela 3630 Laser SystemCandela Corp. · 2006
- 1 generation backK091625 Epicare-Duo Laser SystemLight Age, Inc. · 2009
- This deviceK113115 Epicare YagLight Age, Inc. · 2012
Show all 10 generations
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 9 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 8 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 7 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 6 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 5 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 4 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 3 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 2 generations backK063074 Candela 3630 Laser SystemCandela Corp. · 2006
- 1 generation backK091625 Epicare-Duo Laser SystemLight Age, Inc. · 2009
- This deviceK113115 Epicare YagLight Age, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −9 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −8 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −7 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −6 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −5 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −4 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −3 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −2 | K063074 | Candela 3630 Laser System | Candela Corp. | 2006 | — |
| −1 | K091625 | Epicare-Duo Laser System | Light Age, Inc. | 2009 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K091625 | Epicare-Duo Laser SystemSummary page 1…es C.F.R Section 878.4810 Device Class: 11 Product Code: GEX Predicate Devices Light Age, Inc. EpiCare-DUO Tm Laser System (K091625) Candela, GentleYAG® (K033 172) Cynosure, Apogee EliteTM (K034030) Device Descripition The Light Age Inc. EpiCare-YAG M Laser S… | 2009 |
| * | K033172 | Candela Gentleyag Family of Laser SystemsSummary page 1…878.4810 Device Class: 11 Product Code: GEX Predicate Devices Light Age, Inc. EpiCare-DUO Tm Laser System (K091625) Candela, GentleYAG® (K033 172) Cynosure, Apogee EliteTM (K034030) Device Descripition The Light Age Inc. EpiCare-YAG M Laser System is a Class IV laser surgi… | 2003 |
| * | K034030 | Apogee EliteSummary page 1…11 Product Code: GEX Predicate Devices Light Age, Inc. EpiCare-DUO Tm Laser System (K091625) Candela, GentleYAG® (K033 172) Cynosure, Apogee EliteTM (K034030) Device Descripition The Light Age Inc. EpiCare-YAG M Laser System is a Class IV laser surgical instrument for use in general m… | 2004 |
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 20 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 69 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. 2012, 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-YAG Tm Laser System is intended for use in general and plastic surgery, dermatology, and podiatry for the treatment of vascular lesions, benign pigmented lesions, for the 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…
Read the full statement (269 words)
The Light Age Inc. EpiCare-YAG Tm Laser System is intended for use in general and plastic surgery, dermatology, and podiatry for the treatment of vascular lesions, benign pigmented lesions, for the 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 1-VI including tanned skin.)
Specifically the 1064 nm wavelength is indicated for:
* Removal of unwanted hair, for stable long term or permanent hair reduction 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 and poikiloderma of civatte. Coagulation and hemostasis of soft tissue.
* Benign cutaneous lesions such as warts, scars, striae, and psoriasis
* Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafd 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.
* 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 to periocular wrinkles and perioral wrinkles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113115 · printed Nov 3, 2026
Cite this page
510(k) Report. “K113115: Epicare Yag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K113115
Report an extraction error
Are you the manufacturer?
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