(118 days)
Not Found
No.
The document explicitly states "Not Found" for mentions of AI, DNN, or ML. The therapeutic algorithms described apply fixed modifications to video content, rather than using adaptive or learning-based methods typically associated with AI models.
Yes
The "Intended Use / Indications for Use" states that "Luminopia is a software-only digital therapeutic designed to be used with commercially available Head-Mounted Displays (HMDs)..." and is "indicated for improvement in visual acuity in amblyopia patients". This explicitly defines it as a therapeutic device.
No
Luminopia is described as a "digital therapeutic" and its "Intended Use / Indications for Use" state it is "indicated for improvement in visual acuity in amblyopia patients". The "Device Description" also clarifies that "The Therapeutic Algorithms provide the actual treatment". This indicates its purpose is treatment, not diagnosis.
Yes
The device explicitly states "Luminopia is a software-only digital therapeutic" and "Luminopia is Software as a Medical Device (SaMD) Mobile Application." It clarifies that it uses commercially available Head-Mounted Displays (HMDs) as a computing platform and viewing device, not custom hardware that is part of the medical device itself.
No
The device is a digital therapeutic which provides treatment by modifying video content to improve visual acuity in amblyopia patients. It is not used for in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
Luminopia is a software-only digital therapeutic designed to be used with commercially available Head-Mounted Displays (HMDs) which are compatible with the software application. Luminopia is indicated for improvement in visual acuity in amblyopia patients, aged 4 to to ≤2 line improvement: 31.7% (59/186)
- 2> to ≤3 line improvement: 13.4% (25/186)
- 3> to ≤4 line improvement: 3.8% (7/186)
- 4> to ≤5 line improvement: 3.2% (6/186)
- 5> to ≤6 line improvement: 0.5% (1/186)
- Age 8-12:
- 1> to ≤2 line improvement: 25.0% (26/104)
- 2> to ≤3 line improvement: 11.5% (12/104)
- 3> to ≤4 line improvement: 5.8% (6/104)
- 5> to ≤6 line improvement: 1.0% (1/104)
- 6> to ≤7 line improvement: 1.0% (1/104)
- Age 4-12:
- 1> to ≤2 line improvement: 29.3% (85/290)
- 2> to ≤3 line improvement: 12.8% (37/290)
- 3> to ≤4 line improvement: 4.5% (13/290)
- 4> to ≤5 line improvement: 2.1% (6/290)
- 5> to ≤6 line improvement: 0.7% (2/290)
- 6> to ≤7 line improvement: 0.3% (1/290)
- Adverse Events Rate: Overall 3% (9/290) for Age 4-12.
Predicate Device(s)
Luminopia (Submission Number: K233720)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
FDA 510(k) Clearance Letter - Luminopia
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 9, 2025
Luminopia, Inc.
Scott Xiao
CEO
955 Massachusetts Ave #335
Cambridge, Massachusetts 02139
Re: K243819
Trade/Device Name: Luminopia
Regulation Number: 21 CFR 886.5500
Regulation Name: Digital Therapy Device For Amblyopia
Regulatory Class: Class II
Product Code: QQU
Dated: December 9, 2024
Received: December 12, 2024
Dear Scott Xiao:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Page 3
Sincerely,
Elvin Y. Ng -S
Elvin Ng
Assistant Director
DHT1A: Division of Ophthalmic Devices
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known)
K243819
Device Name
Luminopia
Indications for Use (Describe)
Luminopia is a software-only digital therapeutic designed to be used with commercially available Head-Mounted Displays (HMDs) which are compatible with the software application. Luminopia is indicated for improvement in visual acuity in amblyopia patients, aged 4 to 90 min |
| Weight | Snapdragon 821 |
| Refresh rate | ≥ 60 Hz |
| Field of view | ≥ 51.9 degrees (horizontal)
≥ 30.6 degrees (vertical) |
Substantial Equivalence:
| Feature | Subject Device | Cleared Device | Impact |
Page 7
| Feature | Subject Device (K243819) | Cleared Device (K233720) | Impact |
|---|---|---|---|
| Class | II | II | No change |
| Classification | 886.5500 | 886.5500 | No change |
| Product code | QQU | QQU | No change |
Labeling
| Indications for Use | Luminopia is a software-only digital therapeutic designed to be used with commercially available Head-Mounted Displays (HMDs) which are compatible with the software application. Luminopia is indicated for improvement in visual acuity in amblyopia patients, aged 4 to to ≤7 line improvement | 0.0% (0/186) | 1.0% (1/104) | 0.3% (1/290) |
| 5> to ≤6 line improvement | 0.5% (1/186) | 1.0% (1/104) | 0.7% (2/290) |
| 4> to ≤5 line improvement | 3.2% (6/186) | 0.0% (0/104) | 2.1% (6/290) |
| 3> to ≤4 line improvement | 3.8% (7/186) | 5.8% (6/104) | 4.5% (13/290) |
| 2> to ≤3 line improvement | 13.4% (25/186) | 11.5% (12/104) | 12.8% (37/290) |
| 1> to ≤2 line improvement | 31.7% (59/186) | 25.0% (26/104) | 29.3% (85/290) |
| 0> to ≤1 line improvement | 15.6% (29/186) | 17.3% (18/104) | 16.3% (47/290) |
| No change | 22.6% (42/186) | 26.0% (27/104) | 23.8% (69/290) |
| 0> to ≤1 line decrease | 4.3% (8/186) | 3.8% (4/104) | 4.1% (12/290) |
| 1> to ≤2 line decrease | 4.3% (8/186) | 8.7% (9/104) | 5.9% (17/290) |
| 2> to ≤3 line decrease | 0.5% (1/186) | 0.0% (0/104) | 0.3% (1/290) |
- Based on participants with available data at baseline and one follow-up visit. Categorical variables presented as n/N (%) where N is the number of participants with available data.
- Visual acuity measurements captured using logMAR. A 1-line improvement from baseline corresponds to a change of -0.10 logMAR.
Adverse Events (AEs)
| AE Type | Age 4-7 (N=186) | Age 8-12 (N=104) | Age 4-12 (N=290) |
|---|---|---|---|
| Eye Redness | 0 (0%) | 1 (1%) | 1 ( |