510(k) · Cleared
ClearedPolylase LP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ddc Technologies, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Apr 7, 2004 after an 86-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 59 later devices descend from it.
- Decided
- Apr 7, 2004
- Review
- 86 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
59 later devices descend from it, 1 citing it directly.
- This deviceK040055 Polylase LPDdc Technologies, Inc. · 2004
- Descendant · cites it directly · 58 of its ownK090571 Alma Lasers ALEX755 ModuleAlma Lasers, Ltd. · 2009
- Descendant · 2 generations on · 57 of its ownK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
- Descendant · 3 generations on · 32 of its ownK143519 The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH · 2015
- Descendant · 3 generations on · 22 of its ownK172193 Modified Alma Lasers Soprano XL™ Family ofMulti-Application &…Alma Lasers, Inc. · 2018
- Descendant · 4 generations on · 14 of its ownK222064 The Alma Soprano TitaniumAlma Lasers, Inc. · 2022
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K090571Alma Lasers ALEX755 ModuleAlma Lasers, Ltd. · 2009 · cites it directly58descendants
- K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014 · 2 generations on57descendants
- K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH · 2015 · 3 generations on32descendants
- K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc. · 2018 · 3 generations on22descendants
- K222064The Alma Soprano TitaniumAlma Lasers, Inc. · 2022 · 4 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040055 | Polylase LP | Ddc Technologies, Inc. | 2004 | — |
| +1 | K090571 | Alma Lasers ALEX755 Module | Alma Lasers, Ltd. | 2009 | — |
| +2 | K140009 | Soprano Ice Multi-Application & Multi-Technology Platform | Alma Lasers, Ltd. | 2014 | — |
| +3 | K143519 | The MeDioStar NeXT Family | Asclepion Laser Technologies GmbH | 2015 | — |
| +3 | K172193 | Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology… | Alma Lasers, Inc. | 2018 | — |
| +4 | K222064 | The Alma Soprano Titanium | Alma Lasers, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 8 | 0 |
| 2021 | 3 | 0 |
| 2022 | 10 | 0 |
| 2023 | 6 | 0 |
| 2024 | 8 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (59)
See all 591 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090571 | Alma Lasers ALEX755 Module | 2009 | 58 |
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, K090571 (Alma Lasers, Ltd., 2009) has gone furthest, with 58 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?
1. The POLYLASE LP PULSED DUAL OUTPUT LASER is intended to effect TEMPORARY HAIR REDUCTION in skin types I-IV with 755 nm output wavelength) and skin types IV-VI with 1064 nm output wavelength. 2. The POLYLASE LP PULSED DUAL OUTPUT LASER is also intended to effect STABLE LONG-TERM, OR PERMANENT, HAIR REDUCTION in skin types I-HIL with use of 755 nm wavelength and skin types IV and V with use of 1064 nm wavelength through selective targeting of melanin in…
Read the full statement (145 words)
1. The POLYLASE LP PULSED DUAL OUTPUT LASER is intended to effect TEMPORARY HAIR REDUCTION in skin types I-IV with 755 nm output wavelength) and skin types IV-VI with 1064 nm output wavelength.
2. The POLYLASE LP PULSED DUAL OUTPUT LASER is also intended to effect STABLE LONG-TERM, OR PERMANENT, HAIR REDUCTION in skin types I-HIL with use of 755 nm wavelength and skin types IV and V with use of 1064 nm wavelength through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.
3 FOR PHOTOCOAGULATION AND HEMOSTASIS OF DERMATOLOGICAL VASCULAR LESIONS with 1064 nm output wavelength.
4. FOR INCISION/EXCISION OF SOFT BODY TISSUES IN DERMATOLOGY with 1064 nm output wavelength.
5. FOR NONABLATIVE WRINKLE REDUCTION AND SKIN COLLAGEN REJUVENATION with 1064 nm output w,~vel ngt.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K040055 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040055: Polylase LP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040055
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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