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.

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.

AI/ML Overview

This document does not contain information about acceptance criteria or a study proving the device meets those criteria. Instead, it is a 510(k) Pre-market Notification for the Biocellulase SmoothShapes device, seeking substantial equivalence to legally marketed predicate devices.

The document discusses:

Sponsor and Device Name: Biocellulase, Inc. - SmoothShapes
Predicate Devices: Biocellulase SmoothShapes K053611 and Syneron Medical, Ltd. - VelaSmooth Shaper K050397
Device Description: A system with a main console and an applied part (massage head with rollers, LEDs, and laser diodes) that uses vacuum, massage, and laser light.
Intended Use: 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.
Nonclinical Testing: Software Validation, electrical safety testing, and tissue block testing (to confirm maximal skin temperature rise).
Conclusion: Based on technological characteristics and nonclinical testing, the device is considered as safe and effective as the predicate devices.
FDA Premarket Notification Letter: Confirming the substantial equivalence determination for the stated indications.

The document explicitly states "Nonclinical Testing" and refers to "Software Validation, electrical safety testing and tissue block testing (to confirm maximal skin temperature rise)" but does not present any clinical study data, acceptance criteria, or performance measures against such criteria for its intended uses (e.g., reduction in appearance of cellulite, muscle pain relief).

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, or adjudication methods, as this information is not present in the provided text.

Summary

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Premarket Notification June 7, 2006

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

JUL - 3 2006

Sponsor Name Biocellulase, Inc. One Apple Hill Drive, Suite 316 Natick, MA 01760 Telephone 508-650-4808 Contact Individual: Robert Nagel

1. 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

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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.

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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

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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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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

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Indications for Use

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

Device Name:

Indications For Use:

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

Regulation Number and Section

§ 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.