Sterile Disposable Endocular Probe
FDA 510(k) K884456 · Biophysic Medical, Inc.
510(k) numberK884456
Submission
- Device name
- Sterile Disposable Endocular Probe
- Applicant
- Biophysic Medical, Inc.
Pleasant Hill, CA, US - Received
- October 24, 1988
- Decision date
- December 9, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GEX – Powered Laser Surgical Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology…
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| K262070 | Diode Laser Therapy Systems (DL612A)GEX · Traditional | Hebei Zollvan Medical Technology Co., Ltd. | 08/19/2026SE |
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| K261841 | Q Switched Nd:YAG Laser machine (QLQW-01)GEX · Traditional | Beijing Nubway S&T Co., Ltd. | 08/11/2026SE |
| K261221 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed…GEX · Traditional | Olympus Surgical Technologies America | 07/24/2026SE |
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More from Rhein Laser Technologies Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K953399 | Needle or CutterKNW · Traditional | 10/30/1995SE |
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| K890509 | Indirect Ophthalmoscope Accessory Delivery SystemHQF · Traditional | 03/24/1989SE |
| K884595 | Ophthascan Mini-BIYO · Traditional | 01/03/1989SE |
| K883719 | Interconn. of Ophthalas & Nanolas Laser SystemLQJ · Traditional | 10/18/1988SE |
| K881494 | Four Modifications to Ophthalas Argon/Dye LaserHQF · Traditional | 08/30/1988SN |
| K881459 | Nanolas Nd:Yag Ophthalmic LaserLOI · Traditional | 04/13/1988SE |
| K873460 | Ophthalas Dye Ophthalmic LaserHQF · Traditional | 10/29/1987SE |
| K853116 | PaxialIYO · Traditional | 10/31/1985SE |
| K844686 | Ophthascan BIYO · Traditional | 09/13/1985SE |
Questions and answers
When was Sterile Disposable Endocular Probe cleared by the FDA?
Sterile Disposable Endocular Probe (K884456) received a 510(k) decision of Substantially Equivalent on December 9, 1988, 46 days after the submission was received.
What is the product code of K884456?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.