Dermatology Handpiece-Ophth Laser
FDA 510(k) K833274 · Synemed, Inc.
510(k) numberK833274
Submission
- Device name
- Dermatology Handpiece-Ophth Laser
- Applicant
- Synemed, Inc.
Walker, MI, US - Received
- September 21, 1983
- Decision date
- December 3, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQF – Laser, Ophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4390
- Specialty
- Ophthalmic
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More from Carl Zeiss Meditec
| 510(k) | Device | Decision |
|---|---|---|
| K954037 | Field TrendHPT · Traditional | 11/17/1995SE |
| K852936 | The Fieldmaster Model 275HPT · Traditional | 10/15/1985SE |
| K831085 | Synevac Vacuum Source UnitBTA · Traditional | 06/08/1983SE |
| K828585 | Opthalas Photocoagulator · Traditional | 01/03/1983SE |
| K822853 | Model 200 SquidHPT · Traditional | 10/18/1982SE |
| K813282 | Synevac Vacuum Curettage SystemsHHI · Traditional | 12/14/1981SE |
| K811270 | Scope MasterHIH · Traditional | 09/08/1981SE |
Questions and answers
When was Dermatology Handpiece-Ophth Laser cleared by the FDA?
Dermatology Handpiece-Ophth Laser (K833274) received a 510(k) decision of Substantially Equivalent on December 3, 1983, 73 days after the submission was received.
What is the product code of K833274?
The FDA product code is HQF – Laser, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4390.