510(k) · Cleared
ClearedLight Age Q-Clear Laser, Model 701-1101
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 Feb 25, 2004 as substantially equivalent to K023967 (Palomar Medical Technologies, Inc., 2003) and 5 other predicates after a 139-day review. Its family tree reaches back 4 generations to 1995. 76 later devices descend from it.
- Decided
- Feb 25, 2004
- Review
- 139 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K950019 (1995). 9 ancestors in all. 76 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 3 generations backK973719 Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND:Yag LaserContinuum Biomedical, Inc. · 1997
- 2 generations backK983054 Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag LaserContinuum Biomedical, Inc. · 1999
- 1 generation backK022709 Medlite Q-Swithced LaserContinuum Electro-Optics, Inc. · 2003
- This deviceK033259 Light Age Q-Clear Laser, Model 701-1101Light Age, Inc. · 2004
- Descendant · cites it directly · 39 of its ownK043173 Q-Switched ND:Yag Laser Treatment Head for the Lumenis Quantum SeriesLumenis, Ltd. · 2005
- Descendant · 2 generations on · 38 of its ownK142860 Lumenis M22 SystemLumenis, Ltd. · 2015 · Recalled
- Descendant · cites it directly · 35 of its ownK110370 Q-ClearLight Age, Inc. · 2011
- Descendant · 2 generations on · 34 of its ownK113810 Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc. · 2012
- Descendant · 3 generations on · 33 of its ownK133837 Viora V-TotalViora, Ltd. · 2014
Showing 5 of 76 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 76 · See all- K043173Q-Switched ND:Yag Laser Treatment Head for the Lumenis Quantum SeriesLumenis, Ltd. · 2005 · cites it directly39descendants
- K142860Lumenis M22 SystemLumenis, Ltd. · 2015 · 2 generations on38descendants
- K110370Q-ClearLight Age, Inc. · 2011 · cites it directly35descendants
- K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc. · 2012 · 2 generations on34descendants
- K133837Viora V-TotalViora, Ltd. · 2014 · 3 generations on33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −3 | K973719 | Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND:Yag Laser | Continuum Biomedical, Inc. | 1997 | — |
| −2 | K983054 | Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag Laser | Continuum Biomedical, Inc. | 1999 | — |
| −1 | K022709 | Medlite Q-Swithced Laser | Continuum Electro-Optics, Inc. | 2003 | — |
| 0 (this device) | K033259 | Light Age Q-Clear Laser, Model 701-1101 | Light Age, Inc. | 2004 | — |
| +1 | K043173 | Q-Switched ND:Yag Laser Treatment Head for the Lumenis Quantum Series | Lumenis, Ltd. | 2005 | — |
| +2 | K142860 | Lumenis M22 System | Lumenis, Ltd. | 2015 | 1 |
| +1 | K110370 | Q-Clear | Light Age, Inc. | 2011 | — |
| +2 | K113810 | Modified Alma Lasers Harmony 1064NM (ND:Yag) Modules | Alma Lasers, Inc. | 2012 | — |
| +3 | K133837 | Viora V-Total | Viora, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 8 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 8 | 0 |
| 2021 | 6 | 0 |
| 2022 | 7 | 0 |
| 2023 | 5 | 0 |
| 2024 | 9 | 0 |
| 2025 | 12 | 0 |
| 2026 | 6 | 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? (6)
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 |
|---|---|---|---|
| * | K023967 | Palomar Q-Yag ND:Yag Laser SystemSummary page 1…: Medical Device Class: Regulatory Class II Laser Safety Class: Class IV Laser Product Predicate Devices: - Palomar Q-YAG Tm Nd:YAG Laser System (K023967) - Medlite TM Q-Switched Nd:YAG Laser (K022709 & K983054') - Medlite TM C3 Q-Switched Nd:YAG Laser (KOl 1677)… | 2003 |
| * | K022709 | Medlite Q-Swithced LaserSummary page 1…aser Safety Class: Class IV Laser Product Predicate Devices: - Palomar Q-YAG Tm Nd:YAG Laser System (K023967) - Medlite TM Q-Switched Nd:YAG Laser (K022709 & K983054') - Medlite TM C3 Q-Switched Nd:YAG Laser (KOl 1677) T 1MC6 Q-Switched Nd:YAG Laser (K014… | 2003 |
| * | K983054 | Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag LaserSummary page 1…y Class: Class IV Laser Product Predicate Devices: - Palomar Q-YAG Tm Nd:YAG Laser System (K023967) - Medlite TM Q-Switched Nd:YAG Laser (K022709 & K983054') - Medlite TM C3 Q-Switched Nd:YAG Laser (KOl 1677) T 1MC6 Q-Switched Nd:YAG Laser (K014234)… | 1999 |
| * | K011677 | Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3 Q-Swtiched ND:Yag Laser | 2001 |
| * | K014234 | Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND: Yag LaserSummary page 1…Medlite TM Q-Switched Nd:YAG Laser (K022709 & K983054') - Medlite TM C3 Q-Switched Nd:YAG Laser (KOl 1677) T 1MC6 Q-Switched Nd:YAG Laser (K014234) -Med~ite - Spectra-VRM Q-Switched Nd:YAG Laser System (KO003 17) Description:… | 2002 |
| * | K000317 | Spectra-VRM Q-Switched ND:Yag Laser System, Spectra-VRM | 2000 |
What descends from it? (76)
See all 762 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 9 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K043173 (Lumenis, Ltd., 2005) has gone furthest, with 39 descendants of its own.
- 3 other devices also cite its predicate K023967.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Q-Clear TM Laser is indicated for the following uses: 1. For incision, excision, ablation, and vaporization of soft tissue for General Dermatology 2. The 1064nm wavelength is indicated for: - Dark ink tattoo removal - Removal of pigmented lesions (particularly Nevus of Ota) - Removal or lightening of hair - Skin resurfacing with or without adjuvant preparation - Treatment of common nevi 3. The 532nm wavelength is indicated for: - Removal of…
Read the full statement (122 words)
The Light Age Q-Clear TM Laser is indicated for the following uses:
1. For incision, excision, ablation, and vaporization of soft tissue for General Dermatology
2. The 1064nm wavelength is indicated for:
- Dark ink tattoo removal
- Removal of pigmented lesions (particularly Nevus of Ota)
- Removal or lightening of hair
- Skin resurfacing with or without adjuvant preparation
- Treatment of common nevi
3. The 532nm wavelength is indicated for:
- Removal of light ink (red, tan, purple and orange) tattoos
- Treatment of common nevi
- Treatment of caf&-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 as stated in the FDA summary.
https://510kreport.com/device/K033259 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033259: Light Age Q-Clear Laser, Model 701-1101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033259
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