510(k) · Cleared
ClearedEtherea
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Regulatory Insight, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Apr 6, 2012 after a 220-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 6, 2012
- Review
- 220 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. 2012, 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?
Intense Pulsed Light (IPL-sq) Treatment mild to moderated inflammatory and pustular inflammatory acne vulgaris. (400nm and 640nm filters) The treatment of benign pigmented epidermal lesions including dyschromias, hyperpigmentation, melasma and ephelides (freckles). (540nm and 580nm filters) Lentigines, nevi, and café-au-lait macules. (540nm filter) The treatment of cutaneous lesions including warts, scars and striae. (scars and striae — 540nm, 580nm and…
Read the full statement (264 words)
Intense Pulsed Light (IPL-sq)
Treatment mild to moderated inflammatory and pustular inflammatory acne vulgaris.
(400nm and 640nm filters)
The treatment of benign pigmented epidermal lesions including dyschromias, hyperpigmentation, melasma and ephelides (freckles).
(540nm and 580nm filters)
Lentigines, nevi, and café-au-lait macules.
(540nm filter)
The treatment of cutaneous lesions including warts, scars and striae.
(scars and striae — 540nm, 580nm and 640 filters) (warts - 540nm and 580 filters)
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, and venous malformations.
(540nm and 580nm filters)
The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent hair reduction.
(580nm and 640nm filters)
Infrared (intense IR)
Topical heating for the purpose of elevating tissue’s temperature for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase of local circulation where applied, and the relaxation of muscles. In addition, may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
Laser Nd:Yag 1064nm (1064 LongPulse)
Coagulation and hemostasis of vascular lesions and epidermal tissue, including the treatment of superficial and deep telangiectasias, reticular veins (0,1- 4 mm diameter) of the leg, rosacea, warts, venous lake, leg veins, poikiloderma of Civatte, angiomas, hemangiomas, and nevus;
Non ablative treatment of facial wrinkles, scars and striae;
The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent hair reduction;
Treatment of pseudofolliculitis barbae.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K112505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112505: Etherea.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112505
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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