SMOOTHSHAPES

K061603 · Biocellulase, Inc. · NUV · Jul 3, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061603
• Device Name: SMOOTHSHAPES
• Applicant: Biocellulase, Inc.
• Product Code: NUV · General, Plastic Surgery
• Decision Date: Jul 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Biocellulase SmoothShapes is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.

Device Story

SmoothShapes system comprises main console and handheld applicator connected via umbilical. Applicator features rollers, LEDs, and laser diodes. Device operates by applying vacuum to skin fold between rollers; rollers rotate and slide to manipulate/smooth skin and facilitate tissue mobilization. Laser light provides topical heating to increase tissue temperature. Used in clinical settings; operated by healthcare providers. Output is physical manipulation and thermal energy. Benefits include relief of muscle aches/spasms, improved circulation, and temporary cellulite reduction.

Clinical Evidence

No clinical data. Evidence consists of bench testing only, including software validation, electrical safety testing, and tissue block testing to confirm maximal skin temperature rise.

Technological Characteristics

System includes console and massage head with rollers, LEDs, and laser diodes. Vacuum-assisted mechanical tissue mobilization combined with laser-induced topical heating. Software controls and user interface integrated into console. Electrical safety and tissue temperature testing performed.

Indications for Use

Indicated for individuals experiencing minor muscle aches, pain, or muscle spasms; also for those seeking temporary improvement in local blood circulation and temporary reduction in the appearance of cellulite.

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.

Predicate Devices

• Biocellulase SmoothShapes (K053611)
• Syneron Medical, Ltd. VelaSmooth Shaper (K050397)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image contains a sequence of alphanumeric characters, specifically "KO61663". The characters are written in a handwritten style, with varying stroke thicknesses. The characters are arranged horizontally, with a slight upward slant from left to right.

Premarket Notification June 7, 2006

# 510K Summary of Safety and Effectiveness Biocellulase - SmoothShapes June 1, 2006

JUL - 3 2006

1. Sponsor Name Biocellulase, Inc. One Apple Hill Drive, Suite 316 Natick, MA 01760 Telephone [phone] Contact Individual: Robert Nagel

- 2. Device Name Proprietary Name: SmoothShapes Common/Usual Name: massager/shaper Classification Name: massager, vacuum, light induced heating
# ന് Identification of Predicate or Legally Marketed Device

- Biocellulase SmoothShapes K053611 o
- Syneron Medical, Ltd.- VelaSmooth Shaper K050397

# 4. Device Description

The SmoothShapes system consists of a main console unit and an applied part (massage head with rollers) which is connected to the main console by an umbilical. The main console unit contains the powersupply, hardware, transformers, fuses, cooling fan, mains-input connection, software controls and user interface. The massage head, which is placed against the patient's skin, contains the rollers, LEDs, and laser diodes. The massage head rollers are mobilized in rotation and sliding back and forth. The patient massage is generated by the vacuum introduced to skin fold between the two rollers. The rollers in combination with the vacuum manipulate and smooth out the skin which facilitates tissue mobilization. The laser light provides topical heating which increases tissue temperature.

{1}------------------------------------------------

Biocellulase, Inc. SmoothShapes

#### ട. Intended Use

The Biocellulase SmoothShapes is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.

- Comparison to Predicate Devices 6.
The SmoothShapes is substantially equivalent to the predicates with respect to intended use and technological characteristics.

## 7. Nonclinical Testing

Software Validation, electrical safety testing and tissue block testing (to confirm maximal skin temperature rise) were conducted on the SmoothShapes device.

#### 8. Conclusion

Based on its technological characteristics and the nonclinical testing, the Biocellulase SmoothShapes system is as safe and effective as the abovenamed predicate devices, for the intended use.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows a stylized drawing of three curved lines. The lines are arranged vertically, with each line slightly offset from the others. The lines appear to be flowing or waving, and they are thicker at the top and thinner at the bottom. The drawing is simple and abstract, and it is rendered in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 3 2006

Biocellulase, Inc. c/o Mr. Robert Nagel President One Apple Hill Drive, Suite 316 Natick, Massachusetts 01760

Re: K061603

Trade/Device Name: Biocellulase Smoothshapes 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: NUV Dated: June 19, 2006 Received: June 20, 2006

Dear Mr. Nagel:

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

{3}------------------------------------------------

Page 2 -- Mr. Robert Nagel

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 Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or ar its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Hebert Lemons

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

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known): K C6 160 3

Device Name:

Indications For Use:

The Biocellulase SmoothShapes device is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.

Prescription Use _X __________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Heeler Lemur

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

**510(k) Number** K061663