(78 days)
The Chromos 694 (MEHL) Ruby Laser, Mark I, is indicated for the removal of unwanted body and facial hair.
The Mark I Chromos 694 Ruby Laser is a laser instrument used in medical practice for the removal of unwanted body and facial hair.
The provided text describes a 510(k) premarket notification for the "Chromos 694 Ruby Laser for Hair Removal," seeking substantial equivalence to a predicate device, the "MEHL Ruby Laser for Hair Removal." It does not contain information about specific quantitative acceptance criteria or a dedicated study designed to prove the device meets these criteria in the way typically expected for a new medical device approval with performance metrics like sensitivity, specificity, or accuracy.
Instead, the submission focuses on demonstrating substantial equivalence through:
- Engineering data: Showing similarity in light delivery characteristics.
- Calculations: Proving essentially equivalent fluences for the different spot sizes (5mm vs. 7mm).
- Thermographic profiles: Comparing the optical fiber (new device) to the articulated arm (predicate device).
- Improvements in safety and reliability: Listing features like the elimination of the Q-switched option, replacement of the articulated arm with optical fiber, larger spot size, and software-directed controls with shutdown provisions.
The clinical data mentioned refers to studies performed on the predicate device, not the new Chromos 694 Ruby Laser. The conclusion is that "With the similarity in technical characteristics between the MEHL Ruby Laser and the Chromos 694 Ruby Laser, equivalence in clinical performance can therefore be assured, with more safeguards, better control and increased reliability intrinsic to the newer model."
Therefore, most of the requested information regarding acceptance criteria and a study proving the device meets those criteria is not present in the provided document, as the submission strategy relies on demonstrating substantial equivalence to a previously approved device, rather than new, independent clinical efficacy/safety trials with pre-defined performance endpoints.
Here's a breakdown of what can be extracted and what is not available based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (from K971814) |
|---|---|
| Safety: No unexpected safety issues | Predicate Device (MEHL Ruby Laser): "In clinical studies with the MEHL Ruby Laser, no unexpected safety issues were identified. No scarring or purpuric reactions were observed. Though hyper- and hypopigmentation were seen infrequently, these effects resolved predictably within a few months."New Device (Chromos 694 Ruby Laser): "With the similarity in technical characteristics... equivalence in clinical performance can therefore be assured, with more safeguards, better control and increased reliability intrinsic to the newer model."Improvements: Eliminated Q-switched option, replaced articulated arm with optical fiber (eliminates Gaussian hot spots), software-directed controls and safeguards (including shutdown for 7 fault conditions). |
| Effectiveness (Hair Removal): Equivalent to predicate device | Predicate Device (MEHL Ruby Laser): Used for "removal of unwanted body and facial hair."New Device (Chromos 694 Ruby Laser): "Substantially equivalent to its predecessor... Both use the same wavelength, deliver the same energies to the skin, and are constructed of similar components for the removal of unwanted body and facial hair."Technical Similarity Assessments: Engineering data showing similarity in light delivery, calculations proving essentially equivalent fluences (for 5mm and 7mm spots), thermographic profiles (optical fiber vs. articulated arm). |
| Reliability: Improved or maintained | New Device (Chromos 694 Ruby Laser): "Reliability is improved... Reliability of the newer laser also was assured with a preponderance of quality control and validation information." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The clinical safety data mentioned refers to studies with the predicate device ("In clinical studies with the MEHL Ruby Laser..."), but the number of subjects or cases is not provided.
- Data Provenance: Not specified. It's implied to be clinical data from the predicate device, but no details on country, retrospective/prospective nature are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- This information is not provided. The document relies on technical similarity and historical clinical safety data of the predicate, not a new clinical study with a ground truth established by experts specifically for the Chromos 694 Ruby Laser.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not specified. No new clinical trial with expert adjudication is described for the Chromos 694 Ruby Laser.
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 for hair removal, not an AI-assisted diagnostic tool involving human "readers."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware medical device (laser), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the predicate device's clinical safety, the "ground truth" implicitly referred to observed clinical outcomes (e.g., "no scarring or purpuric reactions were observed," "hyper- and hypopigmentation... resolved predictably"). For the new device, the "ground truth" for its equivalence claim relies on engineering and technical data demonstrating similarity to the predicate, ensuring comparable performance.
8. The sample size for the training set
- Not applicable. This is a hardware device submission, not an AI/machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. (See #8)
{0}------------------------------------------------
MEHL / Biophile International CORPORATION
AUG - 1 1997
4127 N.W. 27th Lane, Suite A Gainesville, Florida 32606 Phone (352) 373-2565 Fax (352) 373-2481
510(k) SUMMARY
CHROMOS 694 RUBY LASER FOR HAIR REMOVAL
The Mark I Chromos 694 Ruby Laser is a laser instrument used in medical practice for the removal of unwanted body and facial hair. Reviewed by the General and Plastic Surgery Device Classification Panel, medical lasers are assigned the Product Code 79GEX and are regulated under 21 CFR 878.4810 as Class II (Performance Standards) devices.
The Mark I Chromos 694 Ruby Laser is substantially equivalent to its predecessor, the MEHL Ruby Laser for Hair Removal. Both use the same wavelength, deliver the same energies to the skin, and are constructed of similar components for the removal of unwanted body and facial hair.
The MEHL Ruby Laser utilized manual controls and a standard, mirrored articulated arm for transmitting laser light to the skin site. Further. it contained a Q-switched feature which was intended for other purposes.
Safety and reliability are improved with the newer version, the Mark I Chromos 694 Ruby Laser. Those improvements include:
- Elimination of the O-switched option ●
- Replacement of the articulated arm with optical fiber which eliminates the . Gausian hot spot common to the former
- . A 7mm vs. 5mm spot size
- Software directed controls and safeguards which include shutdown provisions for no fewer than seven fault conditions
Establishing substantial equivalence between the two devices were (1) engineering data showing similarity in light delivery characteristics; (2) calculations proving essentially equivalent fluences for the 5mm and 7mm spots; and (3) thermographic profiles, optical fiber vs. articulated arm. Reliability of the newer laser also was assured with a preponderance of quality control and validation information.
{1}------------------------------------------------
510(k) Summary Chromos 694 Ruby Laser for Hair Removal Page 2
In clinical studies with the MEHL Ruby Laser, no unexpected safety issues were identified. No scarring or purpuric reactions were observed. Though hyper- and hypopigmentation were seen infrequently, these effects resolved predictably within a few months.
With the similarity in technical characteristics between the MEHL Ruby Laser and the Chromos 694 Ruby Laser, equivalence in clinical performance can therefore be assured, with more safeguards, better control and increased reliability intrinsic to the newer model.
Thomas Blake
Thomas Blake, R.Ph. Regulatory Strategist
6/9/97
Date
{2}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas Blake, R.Ph. MEHL/Biophile International Corporation 48 Mt. Olive Road …………… Budd Lake, New Jersey 07828
AUG - I 1997
Re: K971814
Trade Name: Chromos 694 (MEHL) Ruby Laser, Model Mark I Regulatory Class: II Product Code: GEX Dated: May 14, 1997 Received: May 15, 1997
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 requirements . as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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
{3}------------------------------------------------
Page 2 - Mr. Thomas Blake, R.Ph.
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.
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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
KG711841/A'...
Page _______ of ______________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K971814
Device Name: CHROMOS 694 (MEHL) RUBY LASER, MODEL MARK I
Indications for Use: . . . . . .
The Chromos 694 (MEHL) Ruby Laser, Mark I, is indicated for the removal of unwanted body and facial hair.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K971814 |
Prescription Use_ V (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
$\kappa=37$
§ 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.