(131 days)
To be used with the MEHL Chromos 694 Ruby Laser for the removal of unwanted body and facial hair.
The ChromoScan is a scanner which is used with the Chromos 694 Ruby Laser for the removal of unwanted body and facial hair. The hand held ChromoScan attachment enables treatment of multiple, rather than single hairs, thereby increasing efficiency and adding to the safety of the parent laser. The unit lays down a mathematically precise treatment grid whereby overlap is reduced and thermal recovery time is optimized. It is expected to lessen potential operator error by diminishing the time and tedium associated with one-hair-at-a-time hair removal procedures. Moreover, safeguards within the Chromos 694's intrinsic software insure that the scanner's fluences do not exceed those of the basic laser, i.e., no more than 20J/cm . ChromoScan is substantially equivalent to the other laser delivery attachment, the fiber optic handpiece. Both produce the same spot size, 7mm, and energies, as shown by computergenerated thermographic profiles.
This document is a 510(k) summary for the ChromoScan Scanner, an attachment for a ruby laser used in hair removal. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria or a comprehensive study report on device performance against specific metrics. Therefore, many of the requested details are not present in the provided text.
Here is an analysis based on the available information:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Produce the same spot size as the fiber optic handpiece. | 7mm spot size, same as predicate. |
| Produce the same energies as the fiber optic handpiece. | Same energies as predicate. |
| Fluences do not exceed those of the basic laser (20 J/cm²). | Intrinsic software ensures fluences do not exceed 20 J/cm². |
| Ensure reliability. | Assured by state-of-the-art validation procedures. |
| No concerns about safety during preliminary use. | Preliminary use in Europe produced no safety concerns. |
| Substantial equivalence to predicate device (fiber optic handpiece). | Achieved for spot size, energies, and overall function. |
2. Sample sized used for the test set and the data provenance
The document mentions "Preliminary use of the ChromoScan on subjects in Europe."
- Sample size: Not specified.
- Data provenance: Europe, prospective (implied, as it refers to "preliminary use").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not specified. The document does not describe a formal ground truth establishment process by experts for performance metrics, but rather a general safety observation during preliminary use.
4. Adjudication method for the test set
Not applicable/Not specified. The preliminary use observation for safety does not describe an adjudication method for data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a laser scanner attachment for hair removal, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to a physical medical device like a laser scanner. However, the document emphasizes the scanner's ability to "lessen potential operator error" and lay down a "mathematically precise treatment grid," suggesting that the device's design aims to standardize and improve consistency of treatment application, which could be considered an autonomous function of the device's mechanics/software. There is no specific standalone performance study described for this aspect.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the safety aspect, "no concerns about safety" from preliminary use serves as an informal "ground truth" derived from observation. For technical specifications (spot size, energy), computer-generated thermographic profiles are used for comparison, implying a technical ground truth. There is no mention of pathology or broader outcomes data for the scanner itself.
8. The sample size for the training set
Not applicable. This is a physical device and an attachment, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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JUN 29 1998
MEHL / Biophile International CORPORATION
4127 N.W. 27th Lane, Suite A Gainesville, Florida 32606 Phone (352) 373-2565 Fax (352) 373-2481
510(k) SUMMARY
CHROMOSCAN SCANNER
for the
CHROMOS 694 RUBY LASER FOR HAIR REMOVAL
The ChromoScan is a scanner which is used with the Chromos 694 Ruby Laser for the removal of unwanted body and facial hair. Lasers for such dermatological use were reviewed by the General and Plastic Device Classification Panel and are assigned the Product Code 79 GEX. They are regulated under 21 CFR 878.4810 as Class II devices.
The hand held ChromoScan attachment enables treatment of multiple, rather than single hairs, thereby increasing efficiency and adding to the safety of the parent laser. The unit lays down a mathematically precise treatment grid whereby overlap is reduced and thermal recovery time is optimized. It is expected to lessen potential operator error by diminishing the time and tedium associated with one-hair-at-a-time hair removal procedures. Moreover, safeguards within the Chromos 694's intrinsic software insure that the scanner's fluences do not exceed those of the basic laser, i.e., no more than 20J/cm .
ChromoScan is substantially equivalent to the other laser delivery attachment, the fiber optic handpiece. Both produce the same spot size, 7mm, and energies, as shown by computergenerated thermographic profiles. Reliability of the scanner is assured by state-of-the-art validation procedures and final system inspections.
Preliminary use of the ChromoScan on subjects in Europe produced no concerns about safety.
Ron Bohn
Thomas Blake, R.Ph Regulatory Strategist
5/13/98
Date
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 29 1000
Thomas Blake, R.Ph. ·MEHL/Biophile International Corporation 48 Mt. Olive Road Budd Lake. New Jersey 07828
Re: K980753 Trade Name: Chromoscan Scanner Regulatory Class: II Product Code: GEX Dated: May 27, 1998 Received: May 28, 1998
Dear Mr. Blake:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
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Page 2 - Thomas Blake
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page ______ 1___ of __________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):_ K980753____________________________________________________________________________________________________________________________________________
Device Name: CHROMO SCAN SCANNER____
Indications for Use:
To be used with the MEHL Chromos 694 Ruby Laser for the removal of unwanted body and facial hair.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDEED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | K980753 |
| 510(k) Number |
| Prescription Use (Per 21 CFR 801.109) | X | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|---|---|---|---|
| --------------------------------------- | --- | ---- | ----------------------------------------------- |
§ 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.