510(k) · Cleared
ClearedEnergist Ultraplus Variable Pulsed Light (VPL) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Energist, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Feb 6, 2009 after a 134-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 6, 2009
- Review
- 134 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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?
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.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Energist ULTRA T M VPL Intense Pulsed LightSystem is intended for permanent hair reduction and the treatment of mild to moderate inflammatory Acne Vulgaris. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels and the treatment of benign pigmented lesions. Intense Pulsed Light Energy / wavelengths (530 - 950nm) The 530 - 950nm intense pulsed wavelengths are indicated for: The treatment of…
Read the full statement (208 words)
The Energist ULTRA T M VPL Intense Pulsed LightSystem is intended for permanent hair reduction and the treatment of mild to moderate inflammatory Acne Vulgaris. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels and the treatment of benign pigmented lesions.
Intense Pulsed Light Energy / wavelengths (530 - 950nm)
The 530 - 950nm intense pulsed wavelengths are indicated for:
The treatment of mild to moderate inflammatory Acne Vulgaris.
The treatment of benign pigmented epidermal and cutaneous lesions including warts, scars and striae.
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, Poikiloderma of Civatte, leg veins, facial veins and venous malformations.
Intense Pulsed Light Energy/ wavelengths (610 - 950nm)
The 610 - 950nm intense pulsed wavelengths are indicated for:
The removal of unwanted hair from all skin types and to effect stable long-term or permanent T1 hair reduction in skin types I - V through selective targeting of melanin in hair follicles.
Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
Intense Pulsed Light Energy/wavelengths (415/630 - 950nm)
The treatment of mild to moderate inflammatory Acne Vulgaris.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K082825 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082825: Energist Ultraplus Variable Pulsed Light (VPL) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082825
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026