510(k) · Cleared
ClearedProlite Iii Tower and PR and HR Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantel S.A. · GEX Powered Laser Surgical Instrument
Cleared on Dec 12, 2008 as substantially equivalent to K021304 (Big Sky Laser Technologies, Inc., 2002) after a 239-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Dec 12, 2008
- Review
- 239 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K021304 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK021304 Prolite Pulsed Light SystemBig Sky Laser Technologies, Inc. · 2002
- This deviceK081095 Prolite Iii Tower and PR and HR HandpieceQuantel S.A. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021304 | Prolite Pulsed Light System | Big Sky Laser Technologies, Inc. | 2002 | — |
| 0 (this device) | K081095 | Prolite Iii Tower and PR and HR Handpiece | Quantel S.A. | 2008 | — |
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K021303 | ProLite Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2…ar lesions. G. Conclusion [21 CFR 807.92(b)(3)] Technologically, the ProLite III was found to be substantially equivalent to the currently cleared ProLite (K021303) and Dermalux (K021304). Thus, the risks and benefits for the ProLite III are comparable to the predicate devices. The… | |
| * | K021304 | Prolite Pulsed Light SystemSummary page 1…physical output characteristics as the following predicate devices: ProLite, manufactured by Big Sky Laser Technologies, now Quantel USA (K021304) Dermalux, manufactured by Palomar (KO 10618)… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 ProLite III TM Pulsed Light System with the HR handpiece (containing a 630-1100 nm, 630-990 nm, or 750-1100 nm filter) is intended for the removal of unwanted hair in all Fitzpatrick skin types.
The ProLite III TM Pulsed Light System with the PR handpiece (containing a 530-1100 nm, 550-1100 nm, or 580-1100 nm filter) is intended for the treatment of benign pigmented lesions and the removal of tattoos, the treatment of vascular lesions, and the treatment of shallow veins, telangiectasia, facial hemangiomas, and rosacea vascular lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081095 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081095: Prolite Iii Tower and PR and HR Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081095
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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