HQB — Photocoagulator And Accessories Class II
FDA product code HQB covers "Photocoagulator And Accessories", a Class II medical device regulated under 21 CFR 886.4690. Submissions are reviewed by the Ophthalmic panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HQB
- Device Class
- Class II
- Regulation Number
- 886.4690
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K220263 | vortex surgical | Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex S | November 3, 2022 |
| K191846 | vortex surgical | MAXReach Laser Probe | December 23, 2019 |
| K182646 | vitreq | Vitreq disposable laser probes, light fibers and Chandelier | May 1, 2019 |
| K132614 | peregrine surgical | PEREGRINE CURVED ILLUMINATING LASER PROBE | November 14, 2013 |
| K122997 | peregrine surgical | 23GA CURVED ILLUMINATING LASER PROBE | June 26, 2013 |
| K122905 | peregrine surgical | PEREGRINE 23GA CURVED LASER PROBE | April 30, 2013 |
| K113857 | synergetics | SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE | April 23, 2012 |
| K110951 | alcon research | 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VAL | October 17, 2011 |
| K111493 | nidek co | NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI | July 27, 2011 |
| K110228 | nidek incorporated | NIDEK MULTICOLOR LASER PHOTOCOAGULATOR | February 23, 2011 |
| K964380 | nk-optik america | LC-250 INFRARED LIGHT COAGULATOR | January 22, 1997 |
| K954307 | gamp and assoc | GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBE | December 22, 1995 |
| K954308 | gamp and assoc | GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBE | December 22, 1995 |
| K954306 | gamp and assoc | GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE | December 22, 1995 |
| K923531 | optomed | OPTOSCALPEL I LASER SYSTEM | November 12, 1993 |
| K924090 | endo optics | THE ENDO OPTIKS MICROPROBE | February 1, 1993 |
| K922735 | carl zeiss | ZIESS ENDOPROBE | July 9, 1992 |
| K882679 | surgical laser technologies | SLT CONTACT LASER SYSTEM CYCLOPHOTOCOAGULATION | December 14, 1988 |
| K882441 | surgical laser technologies | SLT CONTACT LASER SYSTEM ENDOPHOTOCOAGULATION | September 26, 1988 |
| K881926 | advanced surgical products | REUSABLE FIBEROPTIC LIGHTPIPE | June 6, 1988 |