← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K041103

# ACNELIFT (K041103)

_Inner Act, LLC · GEX · Jul 27, 2004 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K041103

## Device Facts

- **Applicant:** Inner Act, LLC
- **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md)
- **Decision Date:** Jul 27, 2004
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4810
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic

## Indications for Use

AcneLift " is generally indicated for treatment of dermatological conditions and specifically indicated for the treatment of moderate inflammatory acne vulgaris.

## Device Story

AcneLift uses LED panels emitting visible light at 407 ± 5 nm to treat moderate inflammatory acne vulgaris. Device features mechanical arm for positioning; analog timing device for treatment duration control; fan-cooled aluminum heat sink for thermal management. Treatment area approximately 960 cm²; total light output 42 Watts; fluence 45 mW/cm²; delivers 50 Joules/cm² over 18-20 minutes. Operated by clinician in clinical setting. Light exposure targets acne without UV radiation risks. Output is non-ionizing visible light; clinical decision-making based on dermatological assessment of acne severity.

## Clinical Evidence

No clinical data provided. Substantial equivalence based on analysis of performance characteristics compared to predicate device.

## Technological Characteristics

LED-based light therapy device; 407 ± 5 nm wavelength; 42W total output; 45 mW/cm² fluence; 50 J/cm² energy delivery. Aluminum heat sink with fan cooling. Mechanical arm form factor. Analog timing control. No software.

## Regulatory 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.

## Predicate Devices

- Omnilux Blue ([K030883](/device/K030883.md))

## Submission Summary (Full Text)

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K041103 1 of 2

### FDA 510 K Summary of Safety and Effectiveness for AcneLift

#### 1. General Information

| Submitter:                | Inner Act, LLC<br>4750 Turbo Circle<br>Reno, Nevada 89502<br>775-829-2566<br>Fax: 775-829-7588 |
|---------------------------|------------------------------------------------------------------------------------------------|
| Contact Person:           | Ronnie Lamberton MD<br>At above address, cell: 909-378-9536                                    |
| Summary Preparation Date: | April 12, 2004                                                                                 |

### 2. Names

| Device Name:         | AcneLift                                                              |
|----------------------|-----------------------------------------------------------------------|
| Classification Name: | Laser instrument, surgical, powered device; GEX<br>Class II category. |

#### Predicate Device 3.

AcneLift is substantially equivalent to the Omnilux Blue (K030883)

#### Device Description 4.

AcneLift uses panels of LED's which emit visible light of 407 ± 5 nm and is not associated with the risks or harmful side effects of ultraviolet radiation. Thermal Management is achieved by a fan mounted in close proximity to an aluminum heat sink. The lights are mounted to a mechanical arm and are controlled by an analog timing device. The treatment area is approximately 960 cm4 The total light emitted is 42 Watts giving a fluence of about 45 mW/cm2. Thus, AcneLift provides 50 Joules/cm of energy, in approximately 18-20 minutes.

#### Indications for Use 5.

AcneLift " is generally indicated for treatment of dermatological conditions and specifically indicated for the treatment of moderate inflammatory acne vulgaris.

#### Performance Data 6.

Based on analysis of performance characteristics of Omnilux Blue and AcneLift, Inneract LLC does not believe that any significant differences exist. Therefore, the AcneLift device does not impose any new safety or effectiveness concerns.

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K041103 2 of 2

# "Software"

AcneLift T" does not use any software programs. The treatment time, is controlled by a digital timer which turns off the LED's after the selected time interval.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 27 2004

Ronald W. Lamberton, M.D. Medical Director of Research and Development Inner Act. LLC 4750 Turbo Circle Reno, Nevada 89502

Re: K041103

Trade/Device Name: AcneLift 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 Dated: April 12, 2004 Received: May 20, 2004

Dear Dr. Lamberton:

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 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.

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Page 2 - Ronald W. Lamberton, M.D.

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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

{Celia M. Witten, Ph.D., M.D. 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): _K041103

Device Name: AcneLift

Indications For Use:

AcneLift" is generally indicated for the treatment of dermatological conditions and specifically indicated for the treatment of moderate inflammatory acne vulgaris.

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

Over-The-Counter Use __ (21 CFR 807 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** K041103

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K041103](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K041103)

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