The following data is part of a premarket notification filed by Tti Medical with the FDA for Accu-beam Fiber Optic Handpiece.
| Device ID | K952006 |
| 510k Number | K952006 |
| Device Name: | ACCU-BEAM FIBER OPTIC HANDPIECE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | TTI MEDICAL 7026 KOLL CENTER PKWY. SUITE 207 Pleasanton, CA 94566 |
| Contact | Allen R Howes |
| Correspondent | Allen R Howes TTI MEDICAL 7026 KOLL CENTER PKWY. SUITE 207 Pleasanton, CA 94566 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-28 |
| Decision Date | 1995-05-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B17792110 | K952006 | 000 |
| B177FOR97020 | K952006 | 000 |
| B17710597800 | K952006 | 000 |
| B17710597810 | K952006 | 000 |
| B17710597820 | K952006 | 000 |
| B17710597830 | K952006 | 000 |
| B17710597840 | K952006 | 000 |
| B17710597850 | K952006 | 000 |
| B17710597860 | K952006 | 000 |
| B1779163140 | K952006 | 000 |
| B177950150700 | K952006 | 000 |
| B177ACB160 | K952006 | 000 |
| B1779211010 | K952006 | 000 |
| B17710597380 | K952006 | 000 |
| B17710597390 | K952006 | 000 |
| B17710597400 | K952006 | 000 |
| B177910100 | K952006 | 000 |
| B17710597450 | K952006 | 000 |
| B177ACB11120 | K952006 | 000 |
| B177ACB140 | K952006 | 000 |
| B17710597870 | K952006 | 000 |
| B17710597880 | K952006 | 000 |
| B17710597890 | K952006 | 000 |
| B17710597610 | K952006 | 000 |
| B17710597700 | K952006 | 000 |
| B17710597910 | K952006 | 000 |
| B1779162140 | K952006 | 000 |
| B1779162160 | K952006 | 000 |
| B1770960830 | K952006 | 000 |
| B17791852B0 | K952006 | 000 |
| B17792020 | K952006 | 000 |
| B17710597510 | K952006 | 000 |
| B17710597500 | K952006 | 000 |
| B17710597420 | K952006 | 000 |
| B17710597900 | K952006 | 000 |
| B17710597920 | K952006 | 000 |
| B17710597930 | K952006 | 000 |
| B17710597110 | K952006 | 000 |
| B17710597120 | K952006 | 000 |
| B17710597210 | K952006 | 000 |
| B17710597230 | K952006 | 000 |
| B17710597300 | K952006 | 000 |
| B17792030 | K952006 | 000 |
| B1779185OTO0 | K952006 | 000 |
| 00860009714946 | K952006 | 000 |
| B177911102010 | K952006 | 000 |
| B177911102020 | K952006 | 000 |
| B177911102030 | K952006 | 000 |
| B177205023300 | K952006 | 000 |
| B1779112140 | K952006 | 000 |
| B177950134700 | K952006 | 000 |
| B17720502310 | K952006 | 000 |
| 00860009714939 | K952006 | 000 |
| 00860009714922 | K952006 | 000 |
| 00860009714915 | K952006 | 000 |
| B1779115130 | K952006 | 000 |
| B17700100852P0 | K952006 | 000 |
| B17700100853P0 | K952006 | 000 |
| B17700100991T0 | K952006 | 000 |
| B17710597020 | K952006 | 000 |
| B17700100852T0 | K952006 | 000 |
| B17700100853T0 | K952006 | 000 |
| 00860009714908 | K952006 | 000 |
| B17720502350 | K952006 | 000 |
| B17710598000 | K952006 | 000 |
| B17710598010 | K952006 | 000 |
| B1779205170 | K952006 | 000 |
| B1779206170 | K952006 | 000 |
| B1779207170 | K952006 | 000 |
| B1779208170 | K952006 | 000 |
| B1779209170 | K952006 | 000 |
| B17720502311 | K952006 | 000 |
| B17720502331 | K952006 | 000 |
| B17720502330 | K952006 | 000 |
| B1779204170 | K952006 | 000 |
| B1779203170 | K952006 | 000 |
| B1772020170 | K952006 | 000 |
| B17710598020 | K952006 | 000 |
| B17710598030 | K952006 | 000 |
| B17710598040 | K952006 | 000 |
| B17710598050 | K952006 | 000 |
| B1779154B0 | K952006 | 000 |
| B1771056521MKIT0 | K952006 | 000 |
| B1771056521RKIT0 | K952006 | 000 |
| B1771056522GKIT0 | K952006 | 000 |
| B17720502351 | K952006 | 000 |
| B17792040 | K952006 | 000 |
| B1779111B140 | K952006 | 000 |
| B17791140 | K952006 | 000 |
| B177911417150 | K952006 | 000 |
| B1779114B0 | K952006 | 000 |
| B1779114B140 | K952006 | 000 |
| B17791210 | K952006 | 000 |
| B17791220 | K952006 | 000 |
| B17791230 | K952006 | 000 |
| B17791310 | K952006 | 000 |
| B1779113B140 | K952006 | 000 |
| B1779113B130 | K952006 | 000 |
| B1779113B0 | K952006 | 000 |
| B17791120 | K952006 | 000 |
| B1779112130 | K952006 | 000 |
| B1779112B0 | K952006 | 000 |
| B1779112B120 | K952006 | 000 |
| B1779112B130 | K952006 | 000 |
| B1779112B140 | K952006 | 000 |
| B17791130 | K952006 | 000 |
| B1779113140 | K952006 | 000 |
| B17791320 | K952006 | 000 |
| B17791410 | K952006 | 000 |
| B17791510 | K952006 | 000 |
| B17791851S0 | K952006 | 000 |
| B17791852BS0 | K952006 | 000 |
| B177AC10596200 | K952006 | 000 |
| B177AC10596300 | K952006 | 000 |
| B177AC10596401 | K952006 | 000 |
| B177AC20596200 | K952006 | 000 |
| B177AC20596300 | K952006 | 000 |
| B177AC330MMR0 | K952006 | 000 |
| B17791851BS0 | K952006 | 000 |
| B17791830 | K952006 | 000 |
| B17791820 | K952006 | 000 |
| B17791520 | K952006 | 000 |
| B1779152B0 | K952006 | 000 |
| B17791530 | K952006 | 000 |
| B17791540 | K952006 | 000 |
| B17791550 | K952006 | 000 |
| B17791710 | K952006 | 000 |
| B17791720 | K952006 | 000 |
| B17791810 | K952006 | 000 |
| B177SA10597510 | K952006 | 000 |
| B17792050 | K952006 | 000 |
| B17791930 | K952006 | 000 |
| B17791940 | K952006 | 000 |
| B17791950 | K952006 | 000 |
| B17791960 | K952006 | 000 |
| B17791970 | K952006 | 000 |
| B17791980 | K952006 | 000 |
| B17791990 | K952006 | 000 |
| B1779171L0 | K952006 | 000 |
| B17791920 | K952006 | 000 |
| B17791910 | K952006 | 000 |
| B17791900 | K952006 | 000 |
| B17792060 | K952006 | 000 |
| B17792070 | K952006 | 000 |
| B17792080 | K952006 | 000 |
| B17792090 | K952006 | 000 |
| B177AC140MMM0 | K952006 | 000 |
| B177AC240MMM0 | K952006 | 000 |
| B177AC300MMM0 | K952006 | 000 |
| B177AC90MMM0 | K952006 | 000 |
| B1770960810 | K952006 | 000 |
| B1770960820 | K952006 | 000 |
| B1770960840 | K952006 | 000 |
| B177911102032 | K952006 | 000 |
| B177911102312 | K952006 | 000 |
| B177911102322 | K952006 | 000 |
| B177911102332 | K952006 | 000 |
| B1779111130 | K952006 | 000 |
| B1779111140 | K952006 | 000 |
| B1779111B0 | K952006 | 000 |
| B1779111B120 | K952006 | 000 |
| B177911102022 | K952006 | 000 |
| B177911102012 | K952006 | 000 |
| B17791110 | K952006 | 000 |
| B1770960850 | K952006 | 000 |
| B1770960860 | K952006 | 000 |
| B1770960870 | K952006 | 000 |
| B1770960880 | K952006 | 000 |
| B1770960890 | K952006 | 000 |
| B1770961280 | K952006 | 000 |
| B1770961290 | K952006 | 000 |
| B1770966060 | K952006 | 000 |
| B1779111B130 | K952006 | 000 |