Spectacle, Operating (Loupe), Ophthalmic
An Ophthalmic Operating Spectacle (Loupe) is a wearable magnification device used by surgeons and clinicians to provide enhanced visual detail during ophthalmic examination and surgical procedures. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket notification. It carries product code HOH and is regulated under 21 CFR 886.4770, within the Ophthalmic medical specialty. It is exempt from Good Manufacturing Practice (GMP) requirements.
Research product code HOH in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- HOH
- Device Class
- FDA class 1
- Regulation Number
- 886.4770
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K934494 | SURGITEL | Jan 25, 1994 | Substantially Equivalent | General Scientific Corp. |
| K875124 | LOW-POWER BINOCULAR LOUPE | Feb 19, 1988 | Substantially Equivalent | Seiler Instrument & Mfg. Co., Inc. |
| K810817 | EXETER OPERATING LOUPE | Apr 23, 1981 | Substantially Equivalent | Exeter Instruments, Inc. |
FEI Numbers
This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.