510(k) · Cleared
ClearedPalomar LC 100 Diode Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Palomar Medical Technologies, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Aug 30, 2001 as substantially equivalent to K994225 (Palomar Medical Technologies, Inc., 2000) and 6 other predicates after an 86-day review. Its family tree reaches back 4 generations to 1995. 174 later devices descend from it.
- Decided
- Aug 30, 2001
- Review
- 86 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 4 generations to K950019 (1995). 10 ancestors in all. 174 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 3 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 2 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 1 generation backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- This deviceK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- Descendant · cites it directly · 173 of its ownK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- Descendant · cites it directly · 172 of its ownK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- Descendant · 2 generations on · 171 of its ownK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- Descendant · cites it directly · 169 of its ownK053527 Spectra Hair Removal LaserSpectragenics, Inc. · 2008
- Descendant · 3 generations on · 169 of its ownK072906 SILK'NHome Skinovations, Ltd. · 2008
Showing 5 of 174 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 174 · See all- K032846Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003 · cites it directly173descendants
- K052848Spectra Hair Removal LaserSpectragenics, Inc. · 2005 · cites it directly172descendants
- K060839Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006 · 2 generations on171descendants
- K053527Spectra Hair Removal LaserSpectragenics, Inc. · 2008 · cites it directly169descendants
- K072906SILK'NHome Skinovations, Ltd. · 2008 · 3 generations on169descendants
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 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −2 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −1 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| 0 (this device) | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| +1 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| +1 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| +2 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| +1 | K053527 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2008 | — |
| +3 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 8 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 9 | 0 |
| 2019 | 6 | 0 |
| 2020 | 2 | 0 |
| 2021 | 15 | 0 |
| 2022 | 24 | 0 |
| 2023 | 30 | 0 |
| 2024 | 22 | 0 |
| 2025 | 18 | 0 |
| 2026 | 10 | 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? (7)
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 |
|---|---|---|---|
| * | K994225 | Palomar SLP 2000Summary page 1…in General and Plastic Surgery and in Dermatology (see: 21 CFR 878-4810). Product Code: GEX Panel: 79 Palomar SLP 1000 Diode Laser Palomar Medical Technologies, Inc. K994225; K010580 LightSheer Diode Array Laser Star Medical Technologies, Inc. K973324, K974346, K982940, K001746, K003614 The LC100 del… | 2000 |
| * | K010580 | Palomar SLP 1000Summary page 1…l and Plastic Surgery and in Dermatology (see: 21 CFR 878-4810). Product Code: GEX Panel: 79 Palomar SLP 1000 Diode Laser Palomar Medical Technologies, Inc. K994225; K010580 LightSheer Diode Array Laser Star Medical Technologies, Inc. K973324, K974346, K982940, K001746, K003614 The LC100 delivers inf… | 2001 |
| * | K973324 | Starlight Pulsed Diode Array Laser SystemSummary page 1…duct Code: GEX Panel: 79 Palomar SLP 1000 Diode Laser Palomar Medical Technologies, Inc. K994225; K010580 LightSheer Diode Array Laser Star Medical Technologies, Inc. K973324, K974346, K982940, K001746, K003614 The LC100 delivers infrared laser light with a wavelength of 810 nm, a selectable pulse dura… | 1997 |
| * | K974346 | Starlight Pulsed Diode Array Laser SystemSummary page 1…: GEX Panel: 79 Palomar SLP 1000 Diode Laser Palomar Medical Technologies, Inc. K994225; K010580 LightSheer Diode Array Laser Star Medical Technologies, Inc. K973324, K974346, K982940, K001746, K003614 The LC100 delivers infrared laser light with a wavelength of 810 nm, a selectable pulse duration of 5… | 1998 |
| * | K982940 | Lightsheer Pulsed Diode Array Laser SystemSummary page 1…nel: 79 Palomar SLP 1000 Diode Laser Palomar Medical Technologies, Inc. K994225; K010580 LightSheer Diode Array Laser Star Medical Technologies, Inc. K973324, K974346, K982940, K001746, K003614 The LC100 delivers infrared laser light with a wavelength of 810 nm, a selectable pulse duration of 50 —-1000… | 1999 |
| * | K001746 | Lightsheer Pulsed Diode Array Laser System (Family of Products)Summary page 1…Palomar SLP 1000 Diode Laser Palomar Medical Technologies, Inc. K994225; K010580 LightSheer Diode Array Laser Star Medical Technologies, Inc. K973324, K974346, K982940, K001746, K003614 The LC100 delivers infrared laser light with a wavelength of 810 nm, a selectable pulse duration of 50 —-1000 ms. The c… | 2000 |
| * | K003614 | Lightsheer Pulsed Diode Array Laser SystemSummary page 1…LP 1000 Diode Laser Palomar Medical Technologies, Inc. K994225; K010580 LightSheer Diode Array Laser Star Medical Technologies, Inc. K973324, K974346, K982940, K001746, K003614 The LC100 delivers infrared laser light with a wavelength of 810 nm, a selectable pulse duration of 50 —-1000 ms. The correspond… | 2001 |
What descends from it? (174)
See all 1743 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 6 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K032846 (Spectragenics, Inc., 2003) has gone furthest, with 173 descendants of its own.
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 LC100 diode laser system is indicated for hair removal and permanent hair reduction. Permanent hair reduction is defined as a long-term, stable reduction in the number of re-growing hairs after a treatment regime. The LC100 is also indicated for photocoagulation of dermatological vascular lesions, including port wine stains, telangiectasia, angioma, hemangioma, spider nevi, and other benign vascular lesions; photothermolysis of blood vessels…
Read the full statement (103 words)
The LC100 diode laser system is indicated for hair removal and permanent hair reduction. Permanent hair reduction is defined as a long-term, stable reduction in the number of re-growing hairs after a treatment regime.
The LC100 is also indicated for photocoagulation of dermatological vascular lesions, including port wine stains, telangiectasia, angioma, hemangioma, spider nevi, and other benign vascular lesions; photothermolysis of blood vessels (treatment of facial and leg veins); removal of benign pigmented lesions, including lentigines, nevi, chloasma, and café-au-lait; incision/excision, ablation and coagulation (homeostasis) of soft tissue.
The LC100 is indicated for use in patients with skin types I-VI, including tanned patients.
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/K011747 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011747: Palomar LC 100 Diode Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011747
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026