510(k) · Cleared
ClearedClarity LPC Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lutronic Corporation · GEX Powered Laser Surgical Instrument
Cleared on Nov 22, 2013 as substantially equivalent to K112715 (Candela Corp., 2011) after a 298-day review. Its family tree reaches back 10 generations to 1992. 5 later devices descend from it.
- Decided
- Nov 22, 2013
- Review
- 298 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K910422 (1992). 64 ancestors in all, the oldest K892514 (1990). 5 later devices descend from it, 3 citing it directly.
- 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 backK112715 Candela Gentlemax Family of LasersCandela Corp. · 2011
- This deviceK130199 Clarity LPC Laser SystemLutronic Corporation · 2013
- Descendant · cites it directly · 1 of its ownK183566 CLARITY II Laser SystemLutronic Corporation · 2019 · Recalled
- Descendant · cites it directly · 1 of its ownK161503 ORIONYerim Engineering Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK203788 DermaV Laser SystemLutronic Corporation · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK180224 Element-TLElemenic Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK160227 ACCENTO / HWA Dual/Single laserBison Medical Co, Ltd. · 2016
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 backK112715 Candela Gentlemax Family of LasersCandela Corp. · 2011
- This deviceK130199 Clarity LPC Laser SystemLutronic Corporation · 2013
Most influential descendants
Showing 5 of 5 · See all- K183566CLARITY II Laser SystemLutronic Corporation · 2019 · cites it directly1descendant
- K161503ORIONYerim Engineering Co., Ltd. · 2016 · cites it directly1descendant
- K203788DermaV Laser SystemLutronic Corporation · 2021 · 2 generations on0descendants
- K180224Element-TLElemenic Co., Ltd. · 2018 · 2 generations on0descendants
- K160227ACCENTO / HWA Dual/Single laserBison Medical Co, Ltd. · 2016 · cites it directly0descendants
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 | K112715 | Candela Gentlemax Family of Lasers | Candela Corp. | 2011 | — |
| 0 (this device) | K130199 | Clarity LPC Laser System | Lutronic Corporation | 2013 | — |
| +1 | K183566 | CLARITY II Laser System | Lutronic Corporation | 2019 | 1 |
| +1 | K161503 | ORION | Yerim Engineering Co., Ltd. | 2016 | — |
| +2 | K203788 | DermaV Laser System | Lutronic Corporation | 2021 | 1 |
| +2 | K180224 | Element-TL | Elemenic Co., Ltd. | 2018 | — |
| +1 | K160227 | ACCENTO / HWA Dual/Single laser | Bison Medical Co, Ltd. | 2016 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K112715 | Candela Gentlemax Family of LasersSummary page 1…ER 878.48 10 3. Predicate Devices The CLARITY LPC Laser System is substantially equivalent to the Candela Corporation GentleMAX Family of Laser Systems (K 112715). Page 2 of 11 4. Device Description The CLARITY LPC Laser System contains t… | 2011 |
What descends from it? (5)
3 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 21 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 64 ancestors have a recall of any class.
- Of its descendants, K183566 (Lutronic Corporation, 2019) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K112715.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 CLARITY LPC Laser System 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 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. On all skin types (Fitzpatrick I-VI) including tanned skin. Treatment of benign pigmented…
Read the full statement (294 words)
755nm
The CLARITY LPC Laser System 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 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. On all skin types (Fitzpatrick I-VI) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles.
The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
1064nmi
The CLARITY LPC Laser System is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PEB. 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. The lasers are indicated on all skin types Fitzpatrick 1-VI including tanned skin.
Photocoagulation and hemnostasis 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 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 hypentrophic and keloid scars where vascularity is an integral pant of the scar.
Treatment of wrinkles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130199 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130199: Clarity LPC 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/K130199
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