← Product Code [HQY](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY) · K974414

# MULTI (K974414)

_Morning Calm Corp. · HQY · Dec 8, 1997 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K974414

## Device Facts

- **Applicant:** Morning Calm Corp.
- **Product Code:** [HQY](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY.md)
- **Decision Date:** Dec 8, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.5850
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Indications for Use

Non-prescription sunglasses are for general use to protect eyes from strong sunlight

## Device Story

Non-prescription sunglasses designed to protect eyes from strong sunlight. Device is intended for over-the-counter use by the general population. Functions as a passive optical filter to reduce light intensity and glare. No electronic, software, or active components.

## Clinical Evidence

No clinical data; bench testing only.

## Technological Characteristics

Passive optical device; non-prescription sunglasses; no electronic components or software.

## Regulatory Identification

Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.

## Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
DEC - 8 1997

Mr. Alexander B. Kim
President
Morning Calm Corp.
1106 Seong An Officetel
87-36, Duryu-2Dong, Dalseo-Gu
Daegu, 704-062 Korea

Re: K974414
Trade Name: Sunglasses
Regulatory Class: I
Product Code: 86 HQY
Dated: November 13, 1997
Received: November 24, 1997

Dear Mr. Kim:

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 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.

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Page 2 - Mr. Alexander B. Kim

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) 594-4613. 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,

![img-0.jpeg](img-0.jpeg)

A. Ralph Rosenthal, M.D.
Director
Division of Ophthalmic Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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10(k) Number (if known): K974414

Device Name: Sunglasses

Indications For Use: Non-prescription sunglasses are for general use to protect eyes from strong sunlight

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Am Williams
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K974414

Description Use 21 CFR 801.109)

OR

Over-The-Counter Use ☑

(Optional Format 1-2-96)

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K974414](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K974414)

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