# Iriderm Div.

- Location (FDA's records): Mountain View, CA
- FDA decisions: 10 (1989–1997): 10 510(k) clearances
- Product codes: GEX (8), HQF (2)
- Predicates its devices cite: 11 (3 its own); citations of its devices by later devices: 22 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Frigitronics of Connecticut, Inc.: 2 (https://510kreport.com/company/frigitronics-of-connecticut)
- Metatech Corp.: 2 (https://510kreport.com/company/metatech)
- Coherent Medical Group: 1 (https://510kreport.com/company/coherent-medical-group)
- Alcon Laboratories: 1 (https://510kreport.com/company/alcon-laboratories)
- Continuum Biomedical, Inc.: 1 (https://510kreport.com/company/continuum-biomedical)
- Laserscope: 1 (https://510kreport.com/company/laserscope)

## Firms that cite its devices most
- Iridex Corp: 7 (https://510kreport.com/company/iridex)
- Lumenis, Inc.: 3 (https://510kreport.com/company/lumenis)
- Nidek, Inc.: 2 (https://510kreport.com/company/nidek)
- Asclepion-Meditec AG: 1 (https://510kreport.com/company/asclepion-meditec)
- Norseld Pty., Ltd.: 1 (https://510kreport.com/company/norseld)
- Ceram Optec, Inc.: 1 (https://510kreport.com/company/ceram-optec)
- Quantel Medical: 1 (https://510kreport.com/company/quantel-medical)
- Hoya Conbio, Inc.: 1 (https://510kreport.com/company/hoya-conbio)

## Its most-cited devices
- K964074: Diolite 532 (1997), cited by 8
- K960971: Oculight GL (1996), cited by 5
- K913430: Iris Oculight (R) SLX (1991), cited by 3
- K915236: Iris G-Probe (1994), cited by 2
- K894841: Iris Oculight (TM) SL (1989), cited by 2
- K903288: Iris Oculight SL Diode Laser Photocoag/Modified (1990), cited by 1

## Recent decisions
- K964074: Diolite 532 (Apr 1, 1997)
- K960971: Oculight GL (Aug 28, 1996)
- K960522: Diopexy Probe (Jul 19, 1996)
- K915236: Iris G-Probe (Jul 28, 1994)
- K933211: D'amico\Peyman Fluted Endoprobe (Apr 19, 1994)
- K922663: Iris Oculight SL (Aug 11, 1992)
- K913430: Iris Oculight (R) SLX (Nov 15, 1991)
- K912918: Iris Oculight Diode Laser Adding Slit Lamp Adapter (Aug 23, 1991)

Source page: https://510kreport.com/company/iriderm-div