# K112505: Etherea

- Pathway: 510(k) (Traditional)
- Applicant: Regulatory Insight, Inc.
- Decided: Apr 6, 2012 after 220 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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.

Source page: https://510kreport.com/device/K112505
Methodology: https://510kreport.com/methodology