(220 days)
Not Found
Not Found
No
The provided text describes a multi-platform aesthetic device using IPL, Infrared, and Nd:Yag laser technologies for various dermatological and pain relief applications. There is no mention of AI, ML, image processing, or any data-driven decision-making processes within the device description or performance summaries.
Yes
The device claims to treat various medical conditions like acne, vascular lesions, pain, and scars, which falls under therapeutic use.
No
The provided text only describes the therapeutic uses of the device (treatment of various conditions, pain relief, hair removal). It does not mention any diagnostic capabilities.
No
The intended uses described (IPL, Infrared, Laser Nd:Yag) are all associated with hardware-based energy delivery systems, not software-only devices. The lack of a device description further supports this conclusion.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Intended Use: The intended uses listed for the IPL, Infrared, and Laser components all describe treatments applied directly to the body for various skin conditions, pain relief, and hair removal. They do not involve analyzing samples taken from the body.
Therefore, this device falls under the category of therapeutic or aesthetic medical devices, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX, ONF, ILY
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/1 description: The image contains the logo for the U.S. Department of Health and Human Services. The logo features the department's emblem, which is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare. The emblem is rendered in blue and is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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
1
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 (240) 276-0115. 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 (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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
2
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
3
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