ETHEREA

K112505 · Regulatory Insight, Inc. · GEX · Apr 6, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K112505
• Device Name: ETHEREA
• Applicant: Regulatory Insight, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Etherea is a multi-application laser and light-based system for dermatology and aesthetic procedures. Device utilizes Intense Pulsed Light (IPL-sq), Infrared (Intense IR), and Nd:Yag 1064nm laser modules. Inputs include user-selected wavelengths via interchangeable filters (400-640nm for IPL) and laser energy parameters. System transforms electrical energy into specific light/laser outputs applied to skin or tissue. Operated by clinicians in clinical settings. IPL/Laser outputs target chromophores (melanin, hemoglobin, water) for coagulation, hemostasis, hair reduction, or tissue heating. Infrared module provides topical heating for pain relief and muscle relaxation. Output affects clinical decision-making by enabling non-invasive treatment of vascular/pigmented lesions, hair removal, and musculoskeletal pain management. Benefits include reduced lesion appearance, permanent hair reduction, and temporary pain relief.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparisons to legally marketed devices.

Technological Characteristics

Multi-modal system featuring IPL-sq, Infrared, and Nd:Yag 1064nm laser. IPL uses interchangeable filters (400nm, 540nm, 580nm, 640nm) to target specific chromophores. Nd:Yag 1064nm laser provides long-pulse coagulation and hemostasis. Infrared module provides thermal energy for tissue heating. System is a laser surgical instrument (21 CFR 878.4810).

Indications for Use

Indicated for patients requiring dermatological laser/light therapy for acne, pigmented/vascular lesions, hair removal, scar/striae treatment, and wrinkle reduction; also indicated for patients requiring topical heating for relief of minor muscle/joint pain, stiffness, spasms, and increased local circulation.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Regulatory Insight, Incorporated % Mr. Kevin Walls 5401 S. Cottonwood Court Greenwood Village, Colorado 80121

JUL 1 3 2012

Re: K112505

Trade/Device Name: Etherea Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX, ONF, ILY Dated: March 27, 2012 Received: March 28, 2012

Dear Mr. Walls:

This letter corrects our substantially equivalent letter of April 6, 2012.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Mr. Kevin Walls.

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Richard D. Lyons

FOR Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

# 510(k) Number (if known): K112505

Device Name: Etherea

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)
- V 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)

Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Ogden for mxm

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112505

Page 1 of 2

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### Indications for Use

## 510(k) Number (if known): K112505

Device Name: Etherea

Indications for Use:

### 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.

Prescription Use × Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Oade for mkm

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

112505 · 510(k) Number_ Page 2 of 2