510(k) · Cleared
ClearedFocus Medical 532 Hand Piece Adapter and Dye Pack Accessories (Red or Yellow)
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 Jan 23, 2004 as substantially equivalent to K011677 (Continuum Electro-Optics, Inc., 2001) and 1 other predicate after a 148-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.
- Decided
- Jan 23, 2004
- Review
- 148 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K011677 (2001). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK011677 Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3…Continuum Electro-Optics, Inc. · 2001
- This deviceK032667 Focus Medical 532 Hand Piece Adapter and Dye Pack Accessories (Red…Focus Medical, LLC · 2004
- 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 |
|---|---|---|---|---|---|
| −1 | K011677 | Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3 Q-Swtiched ND:Yag… | Continuum Electro-Optics, Inc. | 2001 | — |
| 0 (this device) | K032667 | Focus Medical 532 Hand Piece Adapter and Dye Pack Accessories (Red or Yellow) | Focus Medical, LLC | 2004 | — |
| +1 | K170850 | Alma Q | Alma Lasers, Ltd. | 2017 | — |
| +2 | K233024 | Alma Harmony | Alma Lasers, Inc. | 2024 | — |
| +3 | K252561 | BTL-754FF | BTL Industries, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | 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…21 CFR 878.481 0 Product Code: GEX Panel: 79 Predicate devices: Continuum Medlite C3 (KOl11677) and C6 Q-Switched (014234) Nd:YAG lasers Device description: The Focus Medical 532 Hand Piece Adapter and the Dye Pack… | 2002 |
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?
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 532 Hand Piece Adapter and the Dye Pack Accessories (Red or Yellow),
when attached to the NaturaLase 1064 Laser, are indicated for:
Tattoo removal
Red inks (532 nm Hand Piece Adapter)
Blue and light blue inks (Yellow Dye Pack)
Green inks (Red Dye Pack)
Treatment of Vascular Lesions - Using the 532 nm Hand Piece Adapter
Port wine birthmark
Telangiectasias
Spider angiomas
Cherry angiomas
Spider nevi
Treatment of Pigmented Lesions - Using the 532 nm Hand Piece Adapter
Café-au-lait birthmarks
Solar lentigines
Senile lentigines
Becker's nevi
Freckles
Nevus spilus
Nevus of ota
Incision, excision, ablation, and vaporization of soft tissue in dermatology - Using the 532 Hand Piece Adapter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032667 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032667: Focus Medical 532 Hand Piece Adapter and Dye Pack Accessories (Red or Yellow).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032667
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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