(78 days)
Not Found
No
The device description focuses on mechanical and light-based mechanisms (rollers, vacuum, LEDs, laser diodes) and does not mention any computational or data-driven components indicative of AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are also marked as "Not Found".
Yes
The 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, which are all therapeutic claims.
No
The device is indicated for therapeutic purposes, such as pain relief, circulation improvement, and cellulite reduction, rather than for diagnosing any condition.
No
The device description clearly outlines hardware components including a main console unit, applied part (massage head with rollers), power supply, transformers, fuses, cooling fan, mains-input connection, key-switch, LEDs, and laser diodes. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the Biocellulase SmoothShapes 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- SmoothShapes Function: The description of the SmoothShapes device clearly indicates it is used directly on the patient's skin for therapeutic purposes (massage, heating, tissue manipulation) to relieve muscle aches, pain, spasms, improve circulation, and reduce the appearance of cellulite. It does not involve testing samples taken from the body.
Therefore, the Biocellulase SmoothShapes device falls under the category of a therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NUV
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 tissue mobilization. The laser light provides topical heating which increases tissue temperature.
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)
Electrical safety testing and tissue block testing (to confirm maximal skin temperature rise) is performed on the SmoothShapes device.
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.
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
K0536!!
Biocellulase. Inc. SmoothShapes
MAR I 5 2006
December 27, 2005
510K Summary of Safety and Effectiveness Biocellulase - SmoothShapes December 27, 2005
-
- Sponsor Name Biocellulase, Inc.
21 Park Ave. Newton, MA. 02458 Telephone 617 733 7077 Contact Individual: Robert Nagel
- Sponsor Name Biocellulase, Inc.
-
- 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
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