510(k) · Cleared
ClearedLorad LT-100 Laser Treatment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Focus Medical, LLC · GEX Powered Laser Surgical Instrument
Cleared on Apr 24, 2000 after a 265-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Apr 24, 2000
- Review
- 265 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK992597 Lorad LT-100 Laser Treatment SystemFocus Medical, LLC · 2000
- Descendant · cites it directly · 2 of its ownK170850 Alma QAlma Lasers, Ltd. · 2017
- Descendant · 2 generations on · 1 of its ownK233024 Alma HarmonyAlma Lasers, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK252561 BTL-754FFBTL Industries, Inc. · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992597 | Lorad LT-100 Laser Treatment System | Focus Medical, LLC | 2000 | — |
| +1 | K170850 | Alma Q | Alma Lasers, Ltd. | 2017 | — |
| +2 | K233024 | Alma Harmony | Alma Lasers, Inc. | 2024 | — |
| +3 | K252561 | BTL-754FF | BTL Industries, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | — | ThermoLase SoftLight Named without a submission number | |
| * | — | Continuum Biomedical, Inc., Medlite Named without a submission number | |
| * | — | Continuum Biomedical, Inc., Medlite IV Q-Switched Nd:YAG Laser Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170850 | Alma Q | 2017 | 2 |
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?
- Of its descendants, K170850 (Alma Lasers, Ltd., 2017) has gone furthest, with 2 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 Lorad LT-100 Laser Treatment System is intended for use: alone or in combination with an adjuvant lotion for the removal or lightening of upwanted facial or body hair. One or two treatments may be required for lightening or removing unwanted hair without the adjuvant lotion; in combination with the adjuvant lotion for skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery; dermal pigmented lesions (dermal…
Read the full statement (115 words)
The Lorad LT-100 Laser Treatment System is intended for use:
alone or in combination with an adjuvant lotion for the removal or lightening of upwanted facial or body hair. One or two treatments may be required for lightening or removing unwanted hair without the adjuvant lotion;
in combination with the adjuvant lotion for skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery;
dermal pigmented lesions (dermal melanocytosis); and
for tattoo removal (dark and blue inks).
The adjuvant lotion is a suspension of carbon powder in a base of Light Mineral Oil, NF.
The Lorad LT-100 Laser Treatment System will be limited to use by licensed professionals (as provided in 21 CFR 801.109).
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/K992597 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992597: Lorad LT-100 Laser Treatment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992597
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