← Product Code [NUV](/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV) · K053611 # SMOOTHSHAPES (K053611) _Bicellulase, Inc. · NUV · Mar 15, 2006 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV/K053611 ## Device Facts - **Applicant:** Bicellulase, Inc. - **Product Code:** [NUV](/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV.md) - **Decision Date:** Mar 15, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for 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 massage head connected via umbilical. Massage head features rollers, LEDs, and laser diodes. Device operates by applying vacuum to skin fold between rollers; rollers rotate and slide to manipulate/smooth skin, facilitating tissue mobilization. Laser light provides topical heating to increase tissue temperature. Used in clinical settings; operated by healthcare professionals. Output is physical tissue manipulation and thermal energy. Benefits include muscle pain/spasm relief, improved circulation, and temporary cellulite reduction. ## Clinical Evidence No clinical data. Evidence consists of bench testing, specifically electrical safety testing and tissue block testing to confirm maximal skin temperature rise. ## Technological Characteristics System includes main console and massage head with rollers, LEDs, and laser diodes. Operates via vacuum-assisted mechanical massage and laser-induced topical heating. Class II device (Product Code: NUV). ## 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 - LPG USA, Inc. Endermology/Therapeutic Massager Vibrator ([K990445](/device/K990445.md)) - Syneron Medical, Ltd. VelaSmooth Shaper ([K050397](/device/K050397.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K0536!! Biocellulase. Inc. SmoothShapes MAR I 5 2006 December 27, 2005 ## 510K Summary of Safety and Effectiveness Biocellulase - SmoothShapes December 27, 2005 - 1. Sponsor Name Biocellulase, Inc. 21 Park Ave. Newton, MA. 02458 Telephone 617 733 7077 Contact Individual: Robert Nagel - 2. Device Name Proprietary Name: SmoothShapes Common/Usual Name: massager/shaper Classification Name: massager, vacuum, light induced heating ### 3. Identification of Predicate or Legally Marketed Device - ் LPG USA, Inc. Endermology/Therapeutic Massager Vibrator -K990445 - Syneron Medical, Ltd.- VelaSmooth Shaper K050397 - ব . 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, and the key-switch. 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 00006. {1}------------------------------------------------ tissue mobilization. The laser light provides topical heating which increases tissue temperature. #### 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. #### 6. Comparison to Predicate Devices The SmoothShapes is substantially equivalent to the predicates with respect to intended use and technological characteristics. #### 7. Nonclinical Testing Electrical safety testing and tissue block testing (to confirm maximal skin temperature rise) is performed 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 the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is written around the circle. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 1 5 2006 Biocellulase, Inc. c/o Mr. Robert Nagel President 21 Park Avenue Newton, Massachusetts 02458 Re: K053611 Trade/Device Name: 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: February 14, 2006 Received: February 14, 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 (240) 276-0115. 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/cdrh/dsma/dsmamain.html Sincerely yours. elmee Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Biocellulase, Inc. SmoothShapes Premarket Notification December 27, 2005 # Indications for Use 510(k) Number (if known): KO536 I l Device Name: Smooth Shapes 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 hlood 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) el.gmb. (Division Sign Off Division of General, Restorative, and Neurological Devices 510(k) Number_ K053611 Page 1 of ____________________________________________________________________________________________________________________________________________________________________ 000016 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV/K053611](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV/K053611) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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