HyPHo Laser System

Hyper Photonics Srl

Country / region:Italy (IT)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Italy (IT)

Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K163449
Device name
HyPHo Laser System
Country / region
Italy(IT)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2016-12-08
Decision date
2017-06-23
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The Hyper Photonics's HYPHO (Ho:YAG) Surgical Laser and Delivery Devices and Accessories (Hyper Photonics optical fibers) is intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including:

- Urology; urinary lithotripsy; arthroscopy; discectomy; E.N.T. surgery; gynecological surgery; pulmonary surgery; gastroenterology surgery; dermatology and plastic surgery and general surgery. 

The HYPHO Laser System and its delivery system (Hyper Photonics optical fibers) are indicated for use in the performance of specific surgical applications as follows:

Urology
- Endoscopic transurethral incision of the prostate (TUIP), bladder neck incision of the prostate (BNI), holmium laser ablation of the prostate (HoLAP), holmium laser resection of the prostate (HoLRP), hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy (BPH)
- Open and endoscopic urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including treatment of:
  ▪ bladder;
  ▪ superficial and invasive bladder, urethral and ureteral tumors;
  ▪ condylomas;
  ▪ lesions of external genitalia;
  ▪ ureteral and penile hemangioma;
  ▪ ureteral strictures;
  ▪ bladder neck obstructions

Urinary Lithotripsy including:
- endoscopic fragmentation of urinary (urethral, ureteral, bladder and renal) calculi, including cystine, calcium oxalate, monohydrate and calcium oxalate dihydrate stones;
- treatment of distal impacted fragments of steinstrasse when guide wires cannot be passed.

Arthroscopy
- Arthroscopy (ablation, excision and coagulation of soft and cartilaginous tissue) in various small and large joints of the body, excluding the spine, including:
  ▪ meniscectomy;
  ▪ plica removal;
  ▪ ligament and tendon release;
  ▪ contouring and sculpting of articular surfaces;
  ▪ debridement of inflamed synovial tissue (synovectomy);
  ▪ loose body debridement;
  ▪ chondromalacia and tears;
  ▪ lateral retinacular release;
  ▪ capsulectomy in the knee;
  ▪ chondroplasty in the knee;
  ▪ chondromalacia ablation.
- Discectomy including:
  ▪ percutaneous vaporization of the L4-5 and L5-S1 lumbar discs of the vertebral spine; open and arthroscopic spine procedures;
  ▪ foraminotomy.

General Surgery
- Open, laparoscopic, and endoscopic general surgery (vaporization, ablation, incision, and coagulation of soft tissue) including:
  ▪ cholecystectomy;
  ▪ lysis of adhesions;
  ▪ appendectomy;
  ▪ biopsy;
  ▪ pylorostenotomy, and removal of polyps of the sigmoid colon;
  ▪ skin incision;
  ▪ tissue dissection;
  ▪ excision of external tumors and lesions;
  ▪ complete or partial resection of internal organs, tumors and lesions;
  ▪ mastectomy;
  ▪ hepatectomy;
  ▪ pancreatectomy;
  ▪ splenectomy;
  ▪ thyroidectomy;
  ▪ parathyroidectomy;
  ▪ herniorrhaphy;
  ▪ tonsillectomy;
  ▪ lymphadenectomy;
  ▪ partial nephrectomy;
  

Intended Use

The Hyper Photonics's HYPHO (Ho:YAG) Surgical Laser and Delivery Devices and Accessories (Hyper Photonics optical fibers) is intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: urology; urinary lithotripsy; arthroscopy; discectomy; E.N.T. surgery; gynecological surgery; pulmonary surgery; gastroenterology surgery; dermatology and plastic surgery and general surgery. The HYPHO Laser System and its delivery system (Hyper Photonics optical fibers) are indicated for use in the performance of specific surgical applications as follows: Urology - Endoscopic transurethral incision of the prostate (TUIP), bladder neck incision of the prostate (BNI), holmium laser ablation of the prostate (HoLAP), holmium laser resection of the prostate (HoLRP), hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy (BPH) - Open and endoscopic urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including treatment of: ▪ bladder; ▪ superficial and invasive bladder, urethral and ureteral tumors; ▪ condylomas; ▪ lesions of external genitalia; ▪ ureteral and penile hemangioma; ▪ ureteral strictures; ▪ bladder neck obstructions Urinary Lithotripsy including: o endoscopic fragmentation of urinary (urethral, ureteral, bladder and renal) calculi, including cystine, calcium oxalate, monohydrate and calcium oxalate dihydrate stones; o treatment of distal impacted fragments of steinstrasse when guide wires cannot be passed. Arthroscopy o Arthroscopy (ablation, excision and coagulation of soft and cartilaginous tissue) in various small and large joints of the body, excluding the spine, including: meniscectomy; plica removal; ligament and tendon release; contouring and sculpting of articular surfaces; debridemnent of inflamed synovial tissue (synovectomy); loose body debridement; chondromalacia and tears; lateral retinecular release; capsulectomy in the knee; chondroplasty in the knee; chondrornalacia ablation. o Discectomy including: percutaneous vaporization of the L4-5 and L5-SI lumbar discs of the vertebral spine; open and arthroscopic spine procedures; foraminotomy. General Surgery o Open, laparoscopic, and endoscopic general surgery (vaporization, ablation, incision, and coagulation of soft tissue) including: cholecystectomy; lysis of adhesions; appendectomy; biopsy. pylorostenoto

Device Description

The device includes a Ho:Yag laser source with 35W max output power at 2100 nm wavelength. The optical delivery system is an optical fiber. The HYPHO Laser System is designed with six major sub-systems, including: (1) Power Supply: a high voltage power supply, which converts and rectifies the AC mains current to provide regulated power for the flash lamp simmer current and main triggering pulse; (2) Cooling System: a cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger; (3) Laser System: a Ho:YAG laser rod, capable of generating laser pulses at 2100 nm wavelength and a frequency up to 30 Hz; (4) Delivery System: an optical delivery system, interfacing the energy from the laser to the patient via an optical fiber and surgical hand piece. A RFID recognition system is included to read the fiber diameter and the number of reuses directly from the fiber equipped with the suitable transponder; (5) PC embedded with 7" display and Control Electronics which regulates the functions of the laser and allows parameter selection by the user, (6) Optical fibers (Hyper optical fibers) equipped with the transponder for recognition of core diameter and for the management of number of reuses. In addition to the six subsystems, the HYPHO Laser System incorporates several safety features, including a remote interlock, an emergency red push button, a footswitch and a key switch. Moreover, the system features two laser emission indicators: a Led stripe located on the top of the frontal panel and a buzzer. The led stripe is green in READY mode and blue in EMISSION mode. The buzzer sounds during laser emission. The HYPHO Laser System is operated via proprietary FW and SW. The SW communicates with embedded FW in the main processor and manages Graphical User Interface (GUI) running on the PC embedded.

Summary parsed at:2026-06-01 05:59:19 UTC

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