510(k) · Cleared
ClearedQ-Clear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Light Age, Inc. · PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Cleared on Sep 15, 2011 as substantially equivalent to K033259 (Light Age, Inc., 2004) and 3 other predicates after a 219-day review. Its family tree reaches back 8 generations to 1994. 35 later devices descend from it.
- Decided
- Sep 15, 2011
- Review
- 219 days
- Class
- Class II
- Product code
- PDZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K936109 (1994). 120 ancestors in all, the oldest K820106 (1982). 35 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 7 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 6 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 5 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 4 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 3 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 2 generations backK083215 Incisive Family of Inpulse ND:Yag LasersIncisive, LLC · 2009
- 1 generation backK093547 Pinpointe FootlaserPinpointe USA, Inc. · 2010
- This deviceK110370 Q-ClearLight Age, Inc. · 2011
- Descendant · cites it directly · 34 of its ownK113810 Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc. · 2012
- Descendant · 2 generations on · 33 of its ownK133837 Viora V-TotalViora, Ltd. · 2014
- Descendant · 3 generations on · 32 of its ownK142093 V20 SystemViora, Ltd. · 2014
- Descendant · 4 generations on · 31 of its ownK150035 V10 systemViora, Ltd. · 2015
- Descendant · 5 generations on · 18 of its ownK153568 InMode Plus SystemInmode MD, Ltd. · 2016
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc. · 2012 · cites it directly34descendants
- K133837Viora V-TotalViora, Ltd. · 2014 · 2 generations on33descendants
- K142093V20 SystemViora, Ltd. · 2014 · 3 generations on32descendants
- K150035V10 systemViora, Ltd. · 2015 · 4 generations on31descendants
- K153568InMode Plus SystemInmode MD, Ltd. · 2016 · 5 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −7 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −6 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −5 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −4 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −3 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −2 | K083215 | Incisive Family of Inpulse ND:Yag Lasers | Incisive, LLC | 2009 | — |
| −1 | K093547 | Pinpointe Footlaser | Pinpointe USA, Inc. | 2010 | — |
| 0 (this device) | K110370 | Q-Clear | Light Age, Inc. | 2011 | — |
| +1 | K113810 | Modified Alma Lasers Harmony 1064NM (ND:Yag) Modules | Alma Lasers, Inc. | 2012 | — |
| +2 | K133837 | Viora V-Total | Viora, Ltd. | 2014 | — |
| +3 | K142093 | V20 System | Viora, Ltd. | 2014 | — |
| +4 | K150035 | V10 system | Viora, Ltd. | 2015 | — |
| +5 | K153568 | InMode Plus System | Inmode MD, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 7 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 11 | 0 |
| 1995 | 8 | 0 |
| 1996 | 10 | 0 |
| 1997 | 12 | 0 |
| 1998 | 11 | 0 |
| 1999 | 6 | 0 |
| 2000 | 9 | 0 |
| 2001 | 9 | 0 |
| 2002 | 9 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 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 PDZ? 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 PDZ device
- #1 K253960 Medicell Mycosis Laser (MCML24004)score 11.3 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K033259 | Light Age Q-Clear Laser, Model 701-1101Summary page 1…ent Classification Panel: General & Plastic Surgery Devices C.F.R. Section 878.4810 Device Class: It Product Code: GEX Predicate Devices: » LightAge Q-Clear™ Laser [K033259], manufactured by Light Age, Inc., 500 Apgar Drive, Somerset, NJ 08873 » Pinpointe FoolLaser™ [K093545 and K093547], manufactur… | 2004 |
| * | K093547 | Pinpointe FootlaserSummary page 1…: GEX Predicate Devices: » LightAge Q-Clear™ Laser [K033259], manufactured by Light Age, Inc., 500 Apgar Drive, Somerset, NJ 08873 » Pinpointe FoolLaser™ [K093545 and K093547], manufactured by Pinpointe USA, Inc, 275 Airpark Boulevard, Suite 100, Chico, CA 95973 » Cutera GenesisPlus Laser System [K103… | 2010 |
| * | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Summary page 1…aser System [K061436), manufactured by Palomar Medical Technologies, Inc. 82 Cambridge Street, Burlington, MA 01803 Family of Altus Medical CoolGlide Aesthetic Lasers [K022226}, manufactured by Altus Medical, Inc. 821 Cowan Road, Burlingame, 'CA 94010 Light Age, Inc.- ' Q-Clear™ Nd:YAG L… | 2002 |
| * | K061436 | Palomar Q-Yag 5 ND:Yag Laser SystemSummary page 1…o, CA 95973 » Cutera GenesisPlus Laser System [K103626], manufactured by Cutera, inc., 3240 Bayshore Bivd., Brisbane, CA 94005 » Palomar Q-YAG 5™ Nd:YAG Laser System [K061436), manufactured by Palomar Medical Technologies, Inc. 82 Cambridge Street, Burlington, MA 01803 Family of Altus Medical CoolGlid… | 2006 |
What descends from it? (35)
See all 351 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113810 | Modified Alma Lasers Harmony 1064NM (ND:Yag) Modules | 2012 | 34 |
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 7 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 120 ancestors have a recall of any class.
- Of its descendants, K113810 (Alma Lasers, Inc., 2012) has gone furthest, with 34 descendants of its own.
- 1 other device also cites its predicate K033259.
How does its category compare?
All PDZ devicesPDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · PDZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PDZ
196in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PDZ
No recall names PDZ since 2007.
Adverse event reports per year · PDZ
1in 2019
MAUDE reports naming product code PDZ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 205 | 0 | 0 |
| 2012 | 6 | 196 | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Light Age, Inc. Q-Clear™ Nd:YAG Laser System is intended for use in general and plastic surgery, dermatology, and podiatry for the incision, excision, vaporization of soft tissues. The Light Age, Inc. Q-Clear™ Nd:YAG Laser is indicated for the following uses: The 1064nm wavelength is indicated for: 1. Podiatry — for incision, excision, vaporization, coagulation of soft tissues including: Matrixectomy Warts including periungual, subungual, and plantar…
Read the full statement (242 words)
The Light Age, Inc. Q-Clear™ Nd:YAG Laser System is intended for use in general and plastic surgery, dermatology, and podiatry for the incision, excision, vaporization of soft tissues. The Light Age, Inc. Q-Clear™ Nd:YAG Laser is indicated for the following uses:
The 1064nm wavelength is indicated for:
1. Podiatry — for incision, excision, vaporization, coagulation of soft tissues including:
Matrixectomy
Warts including periungual, subungual, and plantar warts
Radical nail excision
Neuromas
The Q-Clear™ Laser System is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)
2. Dermatology and Plastic Surgery - for incision, excision, vaporization, coagulation of soft tissues including:
Lesions of the skin and subcutaneous tissue
Spider veins
Plantar Warts
Periungual and subungual warts
Debridement of decubitus ulcer
Treatment of keloids
3. General Dermatology
Dark ink tattoo removal
Treatment of pigmented lesions (particularly Nevus of Ota)
Removal or lightening of hair
Skin resurfacing with or without adjuvant preparation
Treatment of common Nevi
The 532 nm wavelength is indicated for:
1. Dermatology and Plastic Surgery - for incision, excision, vaporization, coagulation of soft tissues including spider veins:
2. General Dermatology
Removal of light ink (red, tan, purple, and orange) tattoos
Treatment of common nevi
Treatment of café-au-lait spots
Treatment of seborrheic keratoses
Treatment of vascular lesions, including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains, and most pigmented lesions (e.g. lentigines, and ephelides)
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/K110370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110370: Q-Clear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110370
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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